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UDIN00261860AM26

Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग

Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली

VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : egtf-dgft@gov.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

Meeting No - NC/3/MEET/Jul/202526/6 Meeting Date - 31/07/2025

Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Jul/202526/6 dated 31/07/2025 under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

  1.     The following members were present in the Meeting:-
Sl. No. Name & Designation Department
1 Shri Dinesh Narain Mathur, Technical Expert Consultant (Pharma)
2 Shri Shaish Kumar, Technical Expert Consultant (Chemical)
3 Shri Nand Lal, Technical Expert Consultant (Chemical)

In attendance:

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAAR( Deputy DGFT ) DGFT ) Date: 19-Aug-2025 18:28:31 Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ) Location:Reason: ramaniagmar@nic.inDGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 19-Aug-2025.

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1 Sh ri Raman Kumar, Deputy DGFT DGFT (HQ)
2<br>Smt. Skina Rani, FTDO<br>DGFT (HQ)<br>3. The Norms Committee has taken decisions only with respect to the technical aspect/ w
Smt. Skina Rani, FTDO DGFT (HQ) 
  1.     The Norms Committee has taken decisions only with respect to the technical aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure, including those in notifications, public notices and policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case. 

  2.     RAs shall ensure compliance with SION, General Notes and Chapter Notes wherever applicable. 

  3.     RAs shall also ensure that authorisation is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard, full compliance with the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4.51 of HBP shall be made.

or as per wastages claimed in the application, whichever is less. In this regard, full compliance with the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4.51 of HBP shall be made.
4. RAs sha l ensure compliance with SION, General Notes and Chapter Notes wherever applic
5 RA h ll l tht thiti i id dd bd th t/
. s sa<br>as ratified by t<br> aso ensure a auorsaon s ssue or reeeme ase on e wasagesconsu<br>he Committee or as per wastages claimed in the application, whichever is less.<br>
regard, full com<br> pliance with the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4<br>
HBP shall be m ade.
Case No. 1 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name CIPLA LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM REVIW00001550AM26
RA File Number 039404000617 AM17
Lic ence No and Date 0310808312/06 /10/2016
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl.No. Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.

d to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl.No. Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>15<br>63 mcl Aerosol Valves<br>As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.<br>Soltel CFC Free /<br>Vertine CFC Free /<br>Pulveril / Neovent<br>Inhaler 25 mcg<br>(120MD) Salmeterol /<br>SOLTEL CFC-FREE<br>1<br>1 Number|ms Committee Decision:<br>e Committee considered the||||case as per||agenda and i|||t was decided to fix ad-hoc norm||s under Para 4.07 of| ||<br>P Vol. I as per details given||||<br>below or as||<br>applied by t|||<br>he firm, whichever is less:-||| |||||||||||||| ||l.No.|Export Product||||Qty.||Sl|I|ort Items|Qt a|lowed| |||||||||.<br>No.||p|y.|.| |||Soltel CFC Free /<br>Vertine CFC Free /||||1 Numb||||||| ||||||||er|15|63|mcl Aerosol Valves|As<br>packin|per<br>g| |||Pulveril / Neovent<br>Inhaler 25 mcg<br>(120MD) Salmeterol /<br>SOLTEL CFC-FREE|||||||||<br>policy<br>and<br>General<br>Notes.|| |||INHALER 25 MCG<br>(with 63 mcl Aerosol<br>Valve, 14 ml<br>Aluminium Can, 0.42||||||24|14 ml Aluminium Can||As<br>per<br>packing<br>policy<br>and||

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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ing<br>policy<br>and||

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Actuator 134 A HFA<br>12.544 gms, Alcohol<br>0.256 gms) General<br>Notes.
43 0.42 mm OD Actuators<br>With Dust Covers / Caps As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
61 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 9.408 gm.
81 ETHANOL 0.256 gm.
2 Foratec Inhaler (CFC<br>Free) (120 MD) /<br>FOROTEL Inhaler (120<br>MD)/ Formoterol 12<br>mcg Inhaler (CFC Free)<br>(120MD) (with 40mcl<br>Aerosol Valve, 10ml<br>Aluminium Can with<br>0.48mm Actuator 134 A<br>HFA 7.84 gms, Alcohol<br>0.16 gms) 1 Number 1 40 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
21 10 ml Aluminium Can As per<br>packing<br>policy and<br>General<br>Notes.
44 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
62 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 5.88 gm.
82 ETHANOL 0.160 gm.
3 Airflusal 25/250 mcg /<br>Fluticort Plus / Seroflo<br>25/250mcg / Seroflo<br>250mcg Inhaler (120 1 Number 10 61mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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br>per<br>packing<br>policy<br>and<br>General|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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MD) Salmeterol 25 mcg<br>(&Fluticasone<br>Propionate 250 mcg<br>Inhaler (120MD) with<br>61mcl Aerosol Valve,14<br>ml Aluminium Can with<br>0.48 mm Actuator 134<br>A HFA 12.50 gms) <br> Notes.
25 14 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
45 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
63 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 8.982 gm.
4 Airflusal 25/125 mcg /<br>Fluticort Plus 125mcg<br>HFA / Seroflo<br>25/125mcg / Seroflo<br>125mcg / Salmeterol 25<br>mcg & Fluticasone<br>(Propionate125 mcg<br>Inhaler (120MD) with<br>61 mcl Aerosol Valve,<br>14 ml Aluminium Can<br>with 0.48 mm<br>Actuator134 AHFA<br>12.50<br>gms) 1 Number 11 61 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
26 14 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
46 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
64 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 8.982 gm.
5 Beclate / Beclort HFA /<br>Beclometasone<br>Dipropionate / Aircort / 1 Number 16 63 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and

luoroethane (<br>HFA 134A Propellant )|8.982 gm.| ||5|Beclate / Beclort HFA /<br>Beclometasone<br>Dipropionate / Aircort /|1 Number|16|63 mcl Aerosol Valves|As<br>per<br>packing<br>policy<br>and|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Beclometasone<br>Pressurised Inhalation /<br>Beclocross (/Beclocip<br>HFA / BECLOMARC<br>FC Free 50 MCG<br>Inhaler (200MD) with<br>63 mcl Aerosol Valve,<br>19 ml Aluminium Can<br>with 0.48 mm Actuator<br>134A HFA 17.772 gms,<br>Alcohol 0.456 gms) General<br>Notes.
31 19 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
47 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
65 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 14.817 gm.
83 ETHANOL 0.456 gm.
6 Beclate / Beclort HFA /<br>Beclometasone<br>Dipropionate / Aircort /<br>Beclometasone<br>Pressurised Inhalation /<br>Beclocross / (Beclocip<br>HFA / BECLOMARC<br>FC Free 100 MCG<br>Inhaler (200 MD) with<br>63 mcl Aerosol Valve,<br>19 ml Aluminium Can<br>with 0.48 mm Actuator<br>134 A HFA 17.304 gms,<br>Alcohol 0.912 gms) <br>1 Number 17 63 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
32 19 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
48 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.

| |||||32|19 ml Aluminium Can|As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.| |||||48|0.48 mm OD Actuators<br>With Dose Counter|As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.| |||||66|1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant )|14.442 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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84 84 ETHANOL ETHANOL 0.912 gm. 0.912 gm.
7 Beclate / Beclort HFA /<br>Beclometasone<br>Dipropionate / Aircort /<br>Beclometasone<br> 1 Number 18 63 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>
Pressurised Inhalation /<br>Beclocross (/ Beclocip<br>HFA / BECLOMARC Notes.
FC Free 200 MCG<br>Inhaler (200 MD) with<br>63 mcl Aerosol Valve<br>,19 ml Aluminium Can<br>with 0.48 mm<br>Actuator134 A HFA<br>16.368 gms, Alcohol 3 19 ml Aluminium Can As<br>packing<br>policy per<br>and
<br>General<br>Notes.
49 0.48 mm OD Actuators As per
1.824 gms) With Dose Counter packing<br>policy<br>and<br>General<br>Notes.
67 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 13.683 gm.
85 ETHANOL 1.824 gm.
8 Beclate<br>Beclom / Beclort HFA /<br>etasone 1 Number 19 63 mcl Aerosol Valves As<br>per<br>packing
Dipropi onate / Aircort / <br>policy<br>and
<br>Beclom <br>etasone <br>General

e<br>Beclom|/ Beclort HFA /<br>etasone|1 Number||19||63 mcl Aerosol Valves||As<br>per<br>packing|| |||Dipropi|onate / Aircort /|||||||<br>policy<br>and|| |||<br>Beclom|<br>etasone|||||||<br>General|| |||Pressuri<br>Beclocr|sed Inhalation /<br>oss /(Beclocip|||||||Notes.|| |||<br>HFA / BECLOMARC<br>FC Free 250 MCG<br>Inhaler (200 MD) with<br>||||34||19 ml Aluminium Can||As<br>per<br>packing<br>policy<br>and|| |||63 mcl Aerosol Valve,<br>19 ml Aluminium Can<br>with 0.48 mm<br>Actuator134A HFA<br>||||||||<br>General<br>Notes.|| ||||||||||||| |||15.900<br>|gms, Alcohol<br>|||50||0.48 mm OD Actuators<br>||As<br>per<br>|| |||2.280 g|ms)|||||With Dose Counter||packing<br> <br>|| |||||||||||policy<br>and<br>Gl|| |||||||||||enera|| |||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Notes.
68 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 13.30 gm.
86 ETHANOL 2.28 gm.
9 Ciclesonide Inhaler 80<br>mcg (120 MD)<br>Ciclohale 80 Inhaler<br>(120 MD) Disbronc 80<br>Inhaler (120 MD )(with<br>50 mcl Aerosol Valve,<br>10 ml Aluminium Can,<br>0.33 Actuator 134A<br>HFA 9.010 gms,<br>Alcohol 0.576 gms) 1 Number 2 50 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
22 10 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
41 0.33 mm OD Actuators<br>With Dust Covers /Caps As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.

||22|10 ml Aluminium Can|As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.| |||||41|0.33 mm OD Actuators<br>With Dust Covers /Caps|As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.| |||||69|1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant )|6.761 gm.| |||||87|ETHANOL|0.58 gm.| ||10|Ciclesonide Inhaler 160<br>mcg (120 MD)<br>Ciclohale 160 Inhaler<br>(120 MD) Disbronc 160<br>Inhaler (120 MD) (with<br>50 mcl Aerosol Valve,<br>10 ml Aluminium Can,<br>0.33 Actuator 134A<br>HFA 8.995 gms,<br>Alcohol 0.576 gms)|1 Number|3|50 mcl Aerosol Valves|As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.| |||||23|10 ml Aluminium Can|As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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42 0.33 mm OD Actuators<br>With Dust Covers /Caps As<br>per<br>packing
policy<br>and<br>General<br>Notes.
70 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 6.746 gm.
88 ETHAN OL 0.58 gm.
11
1 Aerodini / Bulmol /<br>Salcross HFA / Asthalin<br>/ Salair Salbutamol<br>Pressurised Inhalation<br>BP / (SALBUREX 100<br>mcg Inhaler (200 MD)<br>with 50 mcl Aerosol<br>Valve, 19 ml 1 Numb er 4 50 mcl A erosol Valves As<br>p<br>packing<br>policy<br>an er<br>d
General<br>Notes.
35 19 ml Al uminium Can As<br>p<br>ki er

with 50 mcl Aerosol<br>Valve, 19 ml||1 Numb|er|4||50 mcl A|erosol Valves|As<br>p<br>packing<br>policy<br>an|er<br>d| ||||||||||||General<br>Notes.|| ||||||||35||19 ml Al|uminium Can|As<br>p<br>ki|er| ||||Aluminium Can, 0.48<br>Actuator 134A HFA<br>18.20 gms)||||||||pacng<br>policy<br>and<br>General<br>Notes.|| ||||||||51||0.48 mm OD Actuators<br>With Dose Counter||As<br>per<br>packing<br>policy<br>and|| ||||||||||||General<br>|| ||||||||||||Notes.|| |||||||||||||| |||||||||||||| ||||||||71||1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant )||15.20 gm.|| |||||||||||||| |||||||||||||| ||12||Budesp<br>Budeco<br>|ray HFA /<br>rt Budesonide /<br>|1 Number||6||58 mcl Aerosol Valves||As<br>per<br>packing<br> <br>|| ||||BUDEMAR 200 mcg<br>Inhaler (200 MD) (with<br>58mcl Aerosol Valve,<br>19 ml Aluminium Can||||||||policy<br>and<br>General<br>Notes.|| ||||,<br>0.48 Actuator 134A<br>HFA 18.20 gms)||||36||19 ml Aluminium Can||As<br>per<br>packing<br>policy<br>and|| |||||||||||||| ||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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policy<br>and|| |||||||||||||| ||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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General<br>Notes.
52 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
72 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 15.20 gm.
13 Budespray HFA /<br>Budecort Budesonide /<br>BUDEMAR 200 mcg<br>Inhaler (200 MD) (with<br>58mcl Aerosol Valve,<br>19 ml Aluminium Can,<br>0.48 Actuator 134A<br>HFA 18.20 gms) 1 Number 7 58 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
37 19 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
53 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
73 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 15.20 gm.
14 Formoterol Fumarate<br>and Budesonide Inhaler<br>6/100 mcg (120MD) /<br>Foracort 100 Inhaler<br>(120 MD) (with 58mcl<br>Aerosol Valve, 19 ml<br>Aluminium Can, 0.48<br>Actuator 134A HFA<br>12.20 gms) 1 Number 8 58 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
38 19 ml Aluminium Can As<br>per<br>packing

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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||38|19 ml Aluminium Can|As<br>per<br>packing|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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policy<br>and policy<br>and
General
Notes.
54 048 mm OD Attr A<br>r
. cuaos<br>With Dose Counter s<br>pe<br>packing<br>policy<br>and<br>General<br>Notes.
74 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 9.15 gm.
15 Formot erol Fumarate 1 Number 9 58 mcl Aerosol Valves As<br>per
and Bud esonide Inhaler packing
6/200 m<br> cg (120MD) /<br> policy<br>and<br>
Foracor<br>(120MD t 100 Inhaler<br>) (with 58mcl General<br>Notes.
Aerosol Valve, 19 ml
Alumin<br> ium Can, 0.48<br> 39 19 ml Aluminium Can As<br>per
Actuato<br>12.20 g r 134A HFA<br>ms) <br> <br>packing<br>polic<br>and
y<br> <br>General<br>Notes.
55 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing
<br> <br> policy<br>and<br>General<br>
otes.
75 1,1<br>HF ,1,2,Tetrafluoroethane (<br>A 134A Propellant ) 9.15 gm.
16 Beclomethasone<br>Dipropionate 50 mcg<br>and Salbutamol 100 1 Number 5 50 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and

ne (<br>A 134A Propellant )||9.15 gm.|| ||||||||||||||| ||16||Beclomethasone<br>Dipropionate 50 mcg<br>and Salbutamol 100|||1 Number||5|50 mcl Aerosol Valves||As<br>per<br>packing<br>policy<br>and||| ||||<br>mcg Aerocort HFA /<br>Aeroday / Asmabron<br>HFA (Asthalin B<br>Inhaler (200 MD) with||||||||<br> <br>General<br>Notes.||| ||||||||||||||| ||||<br>50 mcl|<br>Aerosol Valve,||||40|19 ml Aluminium Can||As<br>per||| |||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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19 ml Aluminium Can,<br>0.48 Actuator 134A<br>HFA 14.04 gms,<br>Ethanol 0.36 gms) packing<br>policy<br>and<br>General<br>Notes.
56 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
76 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 11.70 gm.
89 ETHANOL 0.36 gm.
17 Fluticasone Propionate /<br>Floair 50mcg Inhaler<br>(120 MD) Flohale /<br>TRUFLO 50 Inhaler<br>(120 MD) (with 61mcl<br>Aerosol Valve, 14 ml<br>Aluminium Can, 0.48<br>Actuator 134A HFA<br>12.50 gms, Ethanol<br>0.256 gms) 1 Number 12 61 mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
27 14 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
57 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
77 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 9.405 gm.
90 ETHANOL 0.26 gm.

0.48 mm OD Actuators<br>With Dose Counter|As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.| |||||77|1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant )|9.405 gm.| |||||90|ETHANOL|0.26 gm.| ||18|Fluticasone Propionate<br>125 mcg Inhaler (120|1 Number|13|61 mcl Aerosol Valves|As<br>per<br>packing|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

11

UDIN00261860AM26

MD) Flohale / TRUFLO<br>125 Inhaler (120MD )<br>(with 61mcl Aerosol<br>Valve, 14 ml<br>Aluminium Can, 0.48<br>Actuator 134A HFA<br>12.50 gms, Ethanol<br>0.256 gms) policy<br>and<br>General<br>Notes.
28 14 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
58 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
78 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant) 9.405 gm.
91 ETHANOL 0.26 gm.
19 Fluticasone Propionate<br>250 mcg Inhaler (120<br>MD) Flohale / TRUFLO<br>250 Inhaler (120 MD)<br>(with 61mcl Aerosol<br>Valve, 14ml Aluminium<br>Can, 0.48 Actuator<br>134A HFA 12.50 gms,<br>Ethanol 0.256 gms) <br> <br>1 Number 14 61mcl Aerosol Valves As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
29 14 ml Aluminium Can As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
59 0.48 mm OD Actuators<br>With Dose Counter As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.
79 1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant ) 9.405 gm.

al<br>Notes.| |||||59|0.48 mm OD Actuators<br>With Dose Counter|As<br>per<br>packing<br>policy<br>and<br>General<br>Notes.| |||||79|1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant )|9.405 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

12

UDIN00261860AM26

92 ETHANOL 0.26 gm. 0.26 gm.
20 Fluticort Plus – 50 mcg 1 Number 20 63 mcl Aerosol Valves As per
HFA / Salmeterol 25 packing
mcg and Fluticasone policy and
Propionate 50 mcg / General
Flunacross S - (50 mcg Notes.
HFA Inhaler (120 MD)
with 63 mcl Aerosol<br>Valve, 14 ml<br>Aluminium Can, 0.48<br>Actuator 134A HFA<br>12.50 gms, Ethanol<br>0.256 gms) 30 14 ml Aluminium Can As<br>packing<br>policy<br>General<br>Notes. per<br> <br>and<br>
60 0.48 mm OD Actuators As per
With Dose Counter packing
policy and
General
Notes.
80 1,1,1,2,Tetrafluoroethane ( 9.405 gm.
HFA 134A Propellant )
93 ETHANOL 0.26 gm.

RA concerned may take further necessary action as per above decision of NC.

| ||||||Notes.|| ||||80|1,1,1,2,Tetrafluoroethane (|9.405|gm.| |||||HFA 134A Propellant )||| ||||93|ETHANOL|0.26 gm.||

RA concerned may take further necessary action as per above decision of NC.

Case No. 2 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name MANNITAB PHARMA SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005338AM24
RA File Number 31AX04000075 AM24
Licence No and<br>Date 3111002606/31/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

13

UDIN00261860AM26

HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
Mannitol Fine Grade F1, F2 & <br>176.0 MT. 1 Mannitol Raw material in 179.52 MT.
F3) in White Powder Form White Powder Form (100-
(16-25 Micron) 150 Micron)

ed.| |---|---|---|---|---| |Mannitol Fine Grade F1, F2 &|<br>176.0 MT.|1|Mannitol Raw material in|179.52 MT.| |F3) in White Powder Form|||White Powder Form (100-|| |(16-25 Micron)|||150 Micron)||

Case No. 3 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name HIKAL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005992AM24
RA File Number 03AX04002781 AM24
Licence No and<br>Date 0311027528/03/10/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,
it was decided to call for following information/documents from the firm:-
Percentage Yield on moler basis for each step of manufacturing process may be furnished.<br>1.
Case No. 4 / NC/3/MEET/Jul/202526/6
Case Status Case Rejected
Party Name KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM REVIW00000628AM25
RA File Number 03AX04003995 AM24
Licence No and 0311029148/06/12/2023

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

14

UDIN00261860AM26

Date

Norms Committee Decision:

The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, the committee didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No. 5 / NC/3/MEET/Jul/202526/6
Case Status Case Rejected
Party Name TIDE INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM REVIW00000622AM25
RA File Number 34AX04000854 AM24
Licence No and<br>Date 3411004626/16/02/2024
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm
has not provided any technical justification / information for enhancement. Hence, the committee didn’t
find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

ny technical justification / information for enhancement. Hence, the committee didn’t|| |find any merit to|review the norms and it was decided torejectthe case maintaining thestatus quo.|
C N 6 / NC/3/MEET/Jl/202526/6
ase o. u
C Stt C Ad
ase aus ase pprove
Pt N EAST AFRICAN INDIA OVERSEAS
ary ame
Meeting Number<br>d Dt NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
an ae
HQ Fil Nb HQRNORM REVIW00001000AM26
e umer
RA Fil Nb 05AX04003662 AM24
e umer
Licence No and<br>Dt 0511024074/26/02/2024
ae
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

15

UDIN00261860AM26

|Import Items|Qty. allowed.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

15

UDIN00261860AM26

Cefiprin 200 Tablet (Cefixime<br>200 mg Tablet (Pack Size - 1 X<br>10'S))<br>1 Number<br>1<br>Cefixime Trihydrate<br>228.294 mg/Tablet<br>Cefiprin 400 Tablet (Cefixime<br>400 mg Tablet (Pack Size - 1 X<br>10'S))<br>1 Number<br>2<br>Cefixime Trihydrate<br>456.588 mg/Tablet<br>Virexim 400 Capsule (Cefixime<br>400 mg Capsule (Pack Size - 10<br>X 10'S))<br>1 Number<br>3<br>Cefixime Trihydrate<br>456.588 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC. Cefiprin 200 Tablet (Cefixime<br>200 mg Tablet (Pack Size - 1 X<br>10'S)) <br> <br>1 Number 1 Cefixime Trihydrate 228.294 mg/Tablet
Cefiprin 400 Tablet (Cefixime<br>400 mg Tablet (Pack Size - 1 X<br>10'S)) <br> <br>1 Number 2 Cefixime Trihydrate 456.588 mg/Tablet
Virexim 400 Capsule (Cefixime<br>400 mg Capsule (Pack Size - 10<br>X 10'S)) <br> <br>1 Number 3 Cefixime Trihydrate 456.588 mg/Tablet

<br> <br>1 Number|2|Cefixime Trihydrate|456.588 mg/Tablet| ||Virexim 400 Capsule (Cefixime<br>400 mg Capsule (Pack Size - 10<br>X 10'S))|<br> <br>1 Number|3|Cefixime Trihydrate|456.588 mg/Tablet|

Case No. 7 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM REVIW00000986AM26
RA File Number 05AX04003663 AM24
Licence No and<br>Date 0511023926/26/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br> before Norms Committee to explain its case along with following information / documents from<br>the firm:<br>Shipping Bill and Bill of Entry.<br>1.
Case No. 8 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name DR.ACHARYA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00002617AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

16

UDIN00261860AM26

| |HQ File Number|HQRNORM APPLY 00002617AM25|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

16

UDIN00261860AM26

RA File Number 03AX04002498 AM25 03AX04002498 AM25
Licence No and<br>Date 0311036513/21/08/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
3-Methoxy-2-methylbenzoyl chloride <br>1 kg. 1 2-Chloro-6-Methoxy 1.10 kg.
(MMBC) Toluene (MCT)
(CAS No.: 24487-91-0) (CAS No.:3260-88-6)
2 Tetrahydrofuran (THF) 0.22 kg.
(CAS No.: 109-99-9)
RA concerned may take further necessary action as per above decision of NC.

o.: 24487-91-0)|||||(CAS No.:3260-88-6)||| |||||2|Tetrahydrofuran (THF)|0.22 kg.|| ||||||(CAS No.: 109-99-9)||| |RA concerned may take further necessary action as per above decision of NC.||||||||

Case No.<br>9 / NC/3/MEET/Jul/202526/6 Case No.<br>9 / NC/3/MEET/Jul/202526/6
Case Status<br>Case Approved
Party Name<br>MICRO LABS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number<br>HQRNORM APPLY 00004984AM25
RA File Number<br>07AX04001544 AM25
Licence No and Date<br>0711013122/23/12/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same
export product/import item in meeting No. NC/3/MEET/Mar/202425/18 dated 17/03/2025 against
advance authorization No. 0711009558 dated 27/10/2023, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty.<br>**Sl. No. ** Import Items Qty.
allowed.
DIRECT COMPRESSION GRANULES 1 kg.<br>1 Phloroglucinol 0.359 kg.
OF PHLOROGLUCINOL 160 MG ODT Dihydrate EP

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

17

UDIN00261860AM26

PREMIX ((EACH 450 mg PREMIX CONTAINS 160 mg Phloroglucinol) contents 534 kg of Phloroglucinol))

Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

17

UDIN00261860AM26

PREMIX ((EACH 450 mg PREMIX CONTAINS 160 mg Phloroglucinol) contents 534 kg of Phloroglucinol))

Case No. 10 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00004983AM25
RA File Number 03AX04004795 AM25
Licence No and<br>Date 0311039828/23/12/2024
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Complete chemistry, chemical reaction and stichometric balance on molar basis with molecular weight and
percentage yield for each step of reaction.
Case No. 11 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00004974AM25
RA File Number 08AX04001582 AM25
Licence No and<br>Date 0811013569/23/12/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of|| |HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

18

UDIN00261860AM26

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Ephedrine Sulfate Injection,<br>USP 50 mg/mL, 1 Ml<br>1 Number<br>1<br>Ephedrine Sulfate USP<br>55.00 mg.<br>RA concerned may take further necessary action as per above decision of NC. Export Product Qty. Sl. No. Import Items Qty. allowed.
Ephedrine Sulfate Injection,<br>USP 50 mg/mL, 1 Ml <br>1 Number 1 Ephedrine Sulfate USP 55.00 mg.

t Product**|Qty.|Sl. No.|Import Items|Qty. allowed.| |---|---|---|---|---|---| ||Ephedrine Sulfate Injection,<br>USP 50 mg/mL, 1 Ml|<br>1 Number|1|Ephedrine Sulfate USP|55.00 mg.|

Case No. 12 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00004969AM25
RA File Number 09AX04000856 AM25
Licence No and<br>Date 0911008680/23/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against<br>advance authorization No**.**0911007744 dated 16/08/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Aspirin and Extended-Release<br>Dipyridamole Capsules 25 mg/200<br>mg Pack Size:60s (Consist of 1080<br>Kgs of Dipyridamole USP)<br>1 Number<br>1<br>Dipyridamole USP<br>204.0 mg/Capsule<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 13 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name VINEET LABORATORIES LIMITED
Meeting Number NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025

ision of NC.||

Case No. 13 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name VINEET LABORATORIES LIMITED
Meeting Number NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

19

UDIN00261860AM26

and Date
HQ File Number<br>HQRNORM APPLY 00004966AM25
RA File Number<br>09AX04000835 AM25
Licence No and<br>Date<br>0911008679/23/12/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same
export product/import item in meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against
advance authorization No**.**0311038141 dated 22/10/2024, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No. Import Items Qty. allowed.
1<br>N Butyl Lithium 30% w/w in<br>1 kg. N-Butyl Chloride 0.540 kg.
Hexane solution
2 Lithium Metal 0.0812 kg.
3 n-Hexane 1.450 kg.
RA concerned may take further necessary action as per above decision of NC.

in<br>1 kg.|N-Butyl Chloride|0.540 kg.|| |Hexane solution|||| |2|Lithium Metal|0.0812 kg.|| |3|n-Hexane|1.450 kg.|| |RA concerned may take further necessary action as per above|decision of NC.|||

Case No.<br>14 / NC/3/MEET/Jul/202526/6
Case Status<br>Case Approved
Party Name<br>RUBICON RESEARCH LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number<br>HQRNORM APPLY 00004993AM25
RA File Number<br>03AX04004754 AM25
Licence No and Date<br>0311039832/23/12/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same
export product/import item in meeting No. NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance
authorization No**.**0311037482 dated 27/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No. Import Items Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

20

UDIN00261860AM26

Naloxon HCL Nasal Spray 4 mg/Spray <br>900000 1 Cont_Holder-PP- Relevant as per
125 ml (Packing metrial Cont_Holder- Numbers White Packing Policy &
PP-White as per export qty)) General Notes with
accountability.

Holder-PP-|Relevant as per| |---|---|---|---|---| |125 ml (Packing metrial Cont_Holder-|Numbers||White|Packing Policy &| |PP-White as per export qty))||||General Notes with| |||||accountability.|
Naloxon HC<br>125 ml (Pack L Nasal Spray 4 mg/Spray<br>ing metrial Cont_Holder- <br>900000<br>Numbers 1 Cont_Holder-PP-<br>White Relevant as per<br>Packing Policy &
PP-White as per export qty))<br>General Notes with<br>accountability.<br>RA concerned may take further necessary action as per above decision of NC. PP-White as per export qty)) General Notes with<br>accountability.
Cas e No. 15 / NC/3/MEET/Jul/2025 26/6
Cas e Status Case Approved
Par ty Name MICRO LABS LIMITED
Me<br>and eting Number<br>Date NC/ 3/ MEET/ Jul/ 202526 / 6 and 31/07/
2025
HQ File Number HQRNORM APPLY 0000 5012AM25
RA File Number 07AX04001543 AM25
Lic<br>Dat ence No and<br>e 0711013126/24/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against<br>advance authorization No**.**0711011543 dated 11/06/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

ort item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against<br>advance authorization No**.0711011543 dated 11/06/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty<br>Sl NoImport Items<br>Qty allowed||||||||||||||| ||Export Product||Qty|||Sl No|||Import Items||||Qty allowed|| |<br>.<br>. . <br>. .<br>Bromocriptine Tablets 2.5 mg.<br>1 Number<br>1<br>Bromocriptine Mesilate<br>BP/EP/IP/USP<br>2.927 mg/Tablet.<br>RA concerned may take further necessary action as per above decision of NC.|||.|||. . |||||||. .**|| ||Bromocriptine Tablets 2.5 mg.||1 Number|||1|||Bromocriptine Mesilate<br>BP/EP/IP/USP||||2.927 mg/Tablet.||

Case No. 16 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name SANOFI CONSUMER HEALTHCARE INDIA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005009AM25
RA File Number 03AX04004794 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

21

UDIN00261860AM26

Licence No and 0311039854/24/12/2024 Date Norms Committee Decision:

me: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

21

UDIN00261860AM26

Licence No and 0311039854/24/12/2024 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Jun/202324/6 dated 14/06/2023 against advance authorization No . 0311021689 dated 24/02/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty.<br>allowed.
Festal Dragees (Tablets) Enterosolube 10 x 10s<br>((Total Net Weight of Pancreatin 3738.32 Kgs<br>Strength of Pancreatin 192 mg/Tablet)) 1 Number<br>Tablet 1 Pancreatin 195.84 mg
Case No. Case No. 17 / NC/3/MEET/Jul/202526/6 17 / NC/3/MEET/Jul/202526/6 17 / NC/3/MEET/Jul/202526/6 17 / NC/3/MEET/Jul/202526/6 17 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005027AM25
RA File Number 09AX04000761 AM25
Licence No and Date 0911008698/24/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No.

0911008698/24/12/2024||||| |Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against<br>advance authorization No**.**0911007027 dated 03/04/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2-Fluoro-6-methoxy pyridine<br>(FMP)<br>1.975 kg<br>Atinvicitinib((or) 1-[(3R,4S)-4-<br>Cyanotetrahydropyran-3-yl]-3-[(2-<br>fluoro-6-methoxy-4-pyridyl)<br>amino]pyrazole-4-carboxamide (L-<br>005251026-Form-I))<br>1 kg<br>2<br>4,5-bis (Diphenylphosphino)-<br>9,9-dimethylxanthane<br>(Xantphos)<br>0.125 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Atinvicitinib((or) 1-[(3R,4S)-4-<br>Cyanotetrahydropyran-3-yl]-3-[(2-<br>fluoro-6-methoxy-4-pyridyl)<br>amino]pyrazole-4-carboxamide (L-<br>005251026-Form-I))||1 kg|1|2-Fluoro-6-methoxy pyridine<br>(FMP)|1.975 kg| |||||2|4,5-bis (Diphenylphosphino)-<br>9,9-dimethylxanthane<br>(Xantphos)|0.125 kg| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

22

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hylxanthane<br>(Xantphos)|0.125 kg| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

22

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Case No. 18 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name DR. DALAVAI'S LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005024AM25
RA File Number 07AX04001494 AM25
Licence No and<br>Date 0711013142/24/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance<br>authorization No**.**0711012501 dated 07/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Minoxidil Intermediate<br>(2,4-Diamino-6-Chlro Pyrimidine)<br>1 kg.<br>1<br>Barbituric Acid<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 19 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name MICRO LABS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005013AM25
RA File Number 07AX04001546 AM25
Licence No and<br>Date 0711013127/24/12/2024
Norms Committee Decision:

3/ MEET/ Jul/ 202526/ 6 and 31/07/2025| |HQ File Number|HQRNORM APPLY 00005013AM25| |RA File Number|07AX04001546 AM25| |Licence No and<br>Date|0711013127/24/12/2024| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

23

UDIN00261860AM26

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance authorization No. 0711012350 dated 18/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

hichever is less:-
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
Dicloxacillin Capsules 500 mg. 1 Number 1 Dicloxacillin Sodium<br>BP/EP/USP 535.0 mg/500 mg<br>Capsule

---|---|---| |Export Product|Qty.|**Sl. No. **|Import Items|Qty. allowed.| |Dicloxacillin Capsules 500 mg.|1 Number|1|Dicloxacillin Sodium<br>BP/EP/USP|535.0 mg/500 mg<br>Capsule|

Case No. 20 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name SHILPA PHARMA LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005050AM25
RA File Number 07AX04001565 AM25
Licence No and<br>Date 0711013151/25/12/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Complete chemistry with molecular weight and Percentage Yield on molar basis.<br>1.<br>Justification for requirement of various enzymes supported by technical literature, and their<br>recovery.<br>2.<br>Past production/consumption data certified by C.A.<br>3.
  1. Justification for requirement of various enzymes supported by technical literature, and their recovery.
Case No. 21 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name ARESKO LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

e|NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

24

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HQ File Number HQRNORM APPLY 00005075AM25
RA File Number 05AX04002970 AM25
Licence No and<br>Date 0511029889/26/12/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Complete technical details for each export item as per Annexures to Appendix 4E.<br>1.
Case No. 22 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005067AM25
RA File Number 03AX04004577 AM25
Licence No and<br>Date 0311039919/26/12/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete chemistry, chemical reaction, and stichometric balance on molar basis with Molecular weight and<br>percentage yield for each step of reaction.

g information/documents from the firm:-<br>Complete chemistry, chemical reaction, and stichometric balance on molar basis with Molecular weight and<br>percentage yield for each step of reaction.||

Case No. 23 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005068AM25
RA File Number 03AX04004874 AM25
Licence No and<br>Date 0311039920/26/12/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

25

UDIN00261860AM26

TE, it was decided to call for following information/documents from the firm:-

Complete chemistry, chemical reaction, and stichometric balance on molar basis with Molecular weight and percentage yield for each step of reaction.

ollowing information/documents from the firm:-

Complete chemistry, chemical reaction, and stichometric balance on molar basis with Molecular weight and percentage yield for each step of reaction.

Case No. 24 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name MICRO LABS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005073AM25
RA File Number 07AX04001547 AM25
Licence No and<br>Date 0711013156/26/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance<br>authorization No**.**0711011047 dated 12/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Premix Of Nifuroxazide (Each<br>gm of Premix contains<br>Nifuroxazide 0.552 gm)<br>12600 kg.<br>1<br>Nifuroxazide BP/EP<br>7024.752 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 25 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005077AM25
RA File Number 03AX04004815 AM25
Licence No and<br>Date 0311039942/26/12/2024

eeting Number<br>and Date|NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025| |HQ File Number|HQRNORM APPLY 00005077AM25| |RA File Number|03AX04004815 AM25| |Licence No and<br>Date|0311039942/26/12/2024|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against advance authorization No . 0311037957 dated 15/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
Azithromycin Dihydrate 1 kg 1 Azithromycin Amine 0.9434 kg.
Case No. Case No. 26 / NC/3/MEET/Jul/202526/6 26 / NC/3/MEET/Jul/202526/6 26 / NC/3/MEET/Jul/202526/6 26 / NC/3/MEET/Jul/202526/6 26 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name USV PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005116AM25
RA File Number 03AX04004920 AM25
Licence No and<br>Date 0311039980/27/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No. NC/3/MEET/Dec/202425/13 dated 07/01/2025 against<br>advance authorization No**.**0311035328 dated 10/07/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import<br>Items<br>**Qty.

ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import<br>Items<br>Qty. allowed.<br>Felodipine ER Tablets 2.5 mg 100s<br>((9,000 Bottles X 100 Per Bottles =<br>9,00,000 Tablets) (Total Weight of<br>Export Product = 2.250 Kgs) (Exempts<br>imported input/material weight inclusive<br>of wastage = 2.368 Kgs))<br>1 Number<br>Tablet<br>1<br>Felodipine<br>2.55 mg/2.5 mg Tablet<br>Felodipine ER Tablets 5.0 mg 100s<br>1 Number<br>2<br>Felodipine<br>5.10 mg/5 mg Tablet||||||| ||Export Product||Qty.|Sl. No.|Import<br>Items|Qty. allowed.| ||Felodipine ER Tablets 2.5 mg 100s<br>((9,000 Bottles X 100 Per Bottles =<br>9,00,000 Tablets) (Total Weight of<br>Export Product = 2.250 Kgs) (Exempts<br>imported input/material weight inclusive<br>of wastage = 2.368 Kgs))||1 Number<br>Tablet|1|Felodipine|2.55 mg/2.5 mg Tablet| ||Felodipine ER Tablets 5.0 mg 100s||1 Number|2|Felodipine|5.10 mg/5 mg Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

27

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s||1 Number|2|Felodipine|5.10 mg/5 mg Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

27

UDIN00261860AM26

((30,000 Bottles X 100 Per Bottles =<br>30,00,000 Tablets) (Total Weight of<br>Export Product = 15.000 Kgs) (Exempts<br>imported input/material weight inclusive<br>of wastage = 15.789 Kgs))<br>Tablet<br>Felodipine ER Tablets 10 mg 100s<br>((15,000 Bottles X 100 Per Bottles =<br>15,00,000 Tablets) (Total Weight of<br>Export Product = 15.000 Kgs) (Exempts<br>imported input/material weight inclusive<br>of wastage = 15.789 Kgs))<br>1 Number<br>Tablet<br>3<br>Felodipine<br>10.20 mg/10 mg Tablet<br>RA concerned may take further necessary action as per above decision of NC. ((30,000 Bottles X 100 Per Bottles =<br>30,00,000 Tablets) (Total Weight of<br>Export Product = 15.000 Kgs) (Exempts<br>imported input/material weight inclusive<br>of wastage = 15.789 Kgs)) Tablet
Felodipine ER Tablets 10 mg 100s<br>((15,000 Bottles X 100 Per Bottles =<br>15,00,000 Tablets) (Total Weight of<br>Export Product = 15.000 Kgs) (Exempts<br>imported input/material weight inclusive<br>of wastage = 15.789 Kgs)) 1 Number<br>Tablet 3 Felodipine 10.20 mg/10 mg Tablet

Tablets) (Total Weight of<br>Export Product = 15.000 Kgs) (Exempts<br>imported input/material weight inclusive<br>of wastage = 15.789 Kgs))|1 Number<br>Tablet|3|Felodipine|10.20 mg/10 mg Tablet|

Case No. Case No. 27 / NC/3/MEET/Jul/202526/6 27 / NC/3/MEET/Jul/202526/6 27 / NC/3/MEET/Jul/202526/6 27 / NC/3/MEET/Jul/202526/6 27 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name VITAL LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005107AM25
RA File Number 03AX04004914 AM25
Licence No and<br>Date 0311039977/27/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Apr/202526/2 dated 08.05.2025 against advance<br>authorization No.0311039829 dated 23.12.2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>9 H Fluorene<br>0.814 kg.<br>2<br>Para Chloro Benzaldehyde<br>0.336 kg.<br>3<br>Methanol<br>3.305 kg.<br>Lumefantrine PH.I<br>1 kg.
Export Product Qty. Sl. No. Import Items Qty. allowed.
Lumefantrine PH.I 1 kg. 1 9 H Fluorene 0.814 kg.
2 Para Chloro Benzaldehyde 0.336 kg.
3 Methanol 3.305 kg.

port Product**||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Lumefantrine PH.I||1 kg.|1|9 H Fluorene|0.814 kg.| |||||2|Para Chloro Benzaldehyde|0.336 kg.| |||||3|Methanol|3.305 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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4<br>Methylene Dichloride (MDC)<br>1.83 kg.<br>5<br>Isopropyl Alcohol<br>0.110 kg.<br>6<br>Dimethyl Formamide<br>0.555 kg.<br>7<br>Chloro Acetyl Chloride<br>0.380 kg.<br>8<br>Sodium Borohydride Powder<br>0.040 kg.<br>9<br>Dibutyl Amine<br>0.390 kg.<br>10<br>N-Butanol<br>0.20 kg.<br>11<br>Ethyl Acetate<br>0.88 kg.<br>RA concerned may take further necessary action as per above decision of NC. 4 Methylene Dichloride (MDC) 1.83 kg.
5 Isopropyl Alcohol 0.110 kg.
6 Dimethyl Formamide 0.555 kg.
7 Chloro Acetyl Chloride 0.380 kg.
8 Sodium Borohydride Powder 0.040 kg.
9 Dibutyl Amine 0.390 kg.
10 N-Butanol 0.20 kg.
11 Ethyl Acetate 0.88 kg.

yl Formamide|0.555 kg.| ||||7|Chloro Acetyl Chloride|0.380 kg.| ||||8|Sodium Borohydride Powder|0.040 kg.| ||||9|Dibutyl Amine|0.390 kg.| ||||10|N-Butanol|0.20 kg.| ||||11|Ethyl Acetate|0.88 kg.|

Case No. Case No. 28 / NC/3/MEET/Jul/202526/6 28 / NC/3/MEET/Jul/202526/6 28 / NC/3/MEET/Jul/202526/6 28 / NC/3/MEET/Jul/202526/6 28 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name AKUMS DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005225AM25
RA File Number 05AX04003442 AM25
Licence No and<br>Date 0511029973/30/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Levonorgestrel EP 1.5 MG Tablet<br>1 Number<br>1<br>Levonorgestrel EP<br>1.53 mg/Tablet
Export Product Qty. Sl. No. Import Items Qty. allowed.
Levonorgestrel EP 1.5 MG Tablet 1 Number 1 Levonorgestrel EP 1.53 mg/Tablet

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

29

UDIN00261860AM26

1|Levonorgestrel EP|1.53 mg/Tablet| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

29

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Case No. 29 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name BIOLOGICAL E. LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005191AM25
RA File Number 09AX04000853 AM25
Licence No and<br>Date 0911008726/30/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Dalbavancin for Injection 500<br>mg per Vial (Each Vial<br>contains 500 mg of<br>Dalbavancin)<br>1 Number<br>1<br>Dalbavancin Hydrochloride<br>535.50 mg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 30 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name MEDIPRAT INTERNATIONAL (INDIA)
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005167AM25
RA File Number 05AX04003369 AM25
Licence No and<br>Date 0511029942/30/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of

03369 AM25| |Licence No and<br>Date|0511029942/30/12/2024| |Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of||

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

30

UDIN00261860AM26

HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
Cocarboxylase HCL<br>50 MG / 2 ML Injection 1 Number 1 CAS 154-87-0<br>Cocarboxylase HCL 55.00 mg/Vial
Case No. Case No. 31 / NC/3/MEET/Jul/202526/6 31 / NC/3/MEET/Jul/202526/6 31 / NC/3/MEET/Jul/202526/6 31 / NC/3/MEET/Jul/202526/6 31 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005164AM25
RA File Number 05AX04003326 AM25
Licence No and<br>Date 0511029939/30/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against advance<br>authorization No. 0511028402 dated 18/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

/import item in meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against advance<br>authorization No. 0511028402 dated 18/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Doxepin<br>Hydrochloride<br>Capsules<br>USP 10 mg.<br>1 Number<br>1<br>Doxepin HCL<br>11.353 mg<br>Doxepin<br>Hydrochloride<br>Capsules<br>USP 25 mg.<br>1 Number<br>2<br>Doxepin HCL<br>28.384 mg<br>Doxepin<br>Hydrochloride<br>Capsules<br>USP 50 mg.<br>1 Number<br>3<br>Doxepin HCL<br>56.766 mg<br>Doxepin<br>Hydrochloride<br>Capsules<br>1 Number<br>4<br>Doxepin HCL<br>85.152 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxepin<br>Hydrochloride<br>Capsules<br>USP 10 mg.||<br>1 Number|1|Doxepin HCL|11.353 mg| ||Doxepin<br>Hydrochloride<br>Capsules<br>USP 25 mg.||<br>1 Number|2|Doxepin HCL|28.384 mg| ||Doxepin<br>Hydrochloride<br>Capsules<br>USP 50 mg.||<br>1 Number|3|Doxepin HCL|56.766 mg| ||Doxepin<br>Hydrochloride<br>Capsules||<br>1 Number|4|Doxepin HCL|85.152 mg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

31

UDIN00261860AM26

psules||<br>1 Number|4|Doxepin HCL|85.152 mg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

31

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USP 75 mg.<br>Doxepin<br>Hydrochloride<br>Capsules<br>USP 100 mg.<br>1 Number<br>5<br>Doxepin HCL<br>113.538 mg<br>RA concerned may take further necessary action as per above decision of NC. USP 75 mg.
Doxepin<br>Hydrochloride<br>Capsules<br>USP 100 mg. <br>1 Number 5 Doxepin HCL 113.538 mg
Case No. Case No. Case No. 32 / NC/3/MEET/Jul/202526/6 32 / NC/3/MEET/Jul/202526/6 32 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005272AM25
RA File Number 03AX04004968 AM25
Licence No and<br>Date 0311040043/31/12/2024
Norms Committee Decision:<br>**:**The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to fix ad-hoc norms as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Cream and Ointment (Imiquimod Cream 5% 0.25 Gm 24? Sachets Total<br>Wet 390 Kgs. (Net Cont. Imiquimod 19.50 Kgs, Polysorbate 15.60 Kgs, Sorbitan<br>2.34 Kgs) )<br>1 Number<br>**S.

y**<br>1<br>Medical Cream and Ointment (Imiquimod Cream 5% 0.25 Gm 24? Sachets Total<br>Wet 390 Kgs. (Net Cont. Imiquimod 19.50 Kgs, Polysorbate 15.60 Kgs, Sorbitan<br>2.34 Kgs) )<br>1 Number<br>S. No<br>Import Product<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 2% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 2% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy & General Notes.<br>Note:|||||| ||Sl. No|Export Product<br>|||Quantity| ||1|Medical Cream and Ointment (Imiquimod Cream 5% 0.25 Gm 24? Sachets Total<br>Wet 390 Kgs. (Net Cont. Imiquimod 19.50 Kgs, Polysorbate 15.60 Kgs, Sorbitan<br>2.34 Kgs) )<br>|||<br> <br>1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 2% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 2% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy & General Notes.|| ||Note:|||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

  • i. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

nkumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

  • i. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.
Case No. 33 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name SAPTAGIR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005275AM25
RA File Number 09AX04000908 AM25
Licence No and<br>Date 0911008741/31/12/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.
Case No. Case No. 34 / NC/3/MEET/Jul/202526/6 34 / NC/3/MEET/Jul/202526/6 34 / NC/3/MEET/Jul/202526/6 34 / NC/3/MEET/Jul/202526/6 34 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name VITAL LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005281AM25
RA File Number 03AX04004988 AM25
Licence No and<br>Date 0311040054/31/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Artemisinin<br>1.04 kg.<br>Artemether PH.I/ USP<br>1 kg.<br>2<br>Trimethyl Ortho Acetate<br>0.50 kg.
Export Product Qty. Sl. No. Import Items Qty.

.<br>Import Items<br>Qty. allowed.<br>1<br>Artemisinin<br>1.04 kg.<br>Artemether PH.I/ USP<br>1 kg.<br>2<br>Trimethyl Ortho Acetate<br>0.50 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Artemether PH.I/ USP||1 kg.|1|Artemisinin|1.04 kg.| |||||2|Trimethyl Ortho Acetate|0.50 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Artesunate PH.I<br>1 kg.<br>3<br>Artemisinin<br>0.80 kg.<br>Dihydro Artemisinin<br>1 kg.<br>4<br>Artemisinin<br>0.92 kg.<br>RA concerned may take further necessary action as per above decision of NC. Artesunate PH.I 1 kg. 3 Artemisinin 0.80 kg.
Dihydro Artemisinin 1 kg. 4 Artemisinin 0.92 kg.
Case No. Case No. 35 / NC/3/MEET/Jul/202526/6 35 / NC/3/MEET/Jul/202526/6 35 / NC/3/MEET/Jul/202526/6 35 / NC/3/MEET/Jul/202526/6 35 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name VITAL LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005282AM25
RA File Number 03AX04004989 AM25
Licence No and<br>Date 0311040055/31/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Artemisinin<br>1.04 kg.<br>Artemether PH.I/ USP<br>1 kg.<br>2<br>Trimethyl Ortho Acetate<br>0.50 kg.<br>Artesunate PH.I<br>1 kg.<br>3<br>Artemisinin<br>0.80 kg.<br>Dihydro Artemisinin<br>1 kg.<br>4<br>Artemisinin<br>0.92 kg.<br>RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Artemether PH.I/ USP||1 kg.|1|Artemisinin|1.04 kg.| |||||2|Trimethyl Ortho Acetate|0.50 kg.| ||Artesunate PH.I||1 kg.|3|Artemisinin|0.80 kg.| ||Dihydro Artemisinin||1 kg.|4|Artemisinin|0.92 kg.| |||||action as per above decision of NC.|||

Case No. 36 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
PartyName ZENTIVA PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

Approved| |PartyName|ZENTIVA PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005289AM25
RA File Number 03AX04005012 AM25
Licence No and<br>Date 0311040059/31/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Sep/202324/14 dated 27/09/2023 against advance<br>authorization No. 0311027099 dated 14/09/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Acetyl Salicylic acid 75 mg<br>Film coated Tablets (Net Wt.<br>Acetyl Salicylic Acid 900.00<br>KGS))<br>1 Number<br>1<br>Acetyl Salicylic Acid<br>76.50 mg/Tablet<br>**Note:**The Committee also recommended making new SION for above export product.<br>RA concerned may take further necessary action as per above decision of NC.

icylic Acid<br>76.50 mg/Tablet<br>**Note:**The Committee also recommended making new SION for above export product.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 37 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name ALCHYMARS ICM SM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005290AM25
RA File Number 04AX04000666 AM25
Licence No and<br>Date 0411008818/31/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Sep/202324/14 dated 27/09/2023 against advance

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

authorization No. 0411005827 dated 07/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty.<br>allowed.
Clindamycin Hydrochloride Active<br>Pharmaceutical Ingredient 1 kg 1 Lincomycin Hydrochloride<br>Raw Material 1.43 kg

*Sl. No.**|Import Items|Qty.<br>allowed.| |---|---|---|---|---| |Clindamycin Hydrochloride Active<br>Pharmaceutical Ingredient|1 kg|1|Lincomycin Hydrochloride<br>Raw Material|1.43 kg|

Case No. Case No. 38 / NC/3/MEET/Jul/202526/6 38 / NC/3/MEET/Jul/202526/6 38 / NC/3/MEET/Jul/202526/6 38 / NC/3/MEET/Jul/202526/6 38 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name SCL LIFESCIENCES LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005308AM25
RA File Number 30AX04000553 AM25
Licence No and Date 3011006288/31/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No. 3011004726 dated 29/01/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>1<br>2-Iodo benzoic acid<br>0.94 kg.<br>QUETI-VII-R<br>(Crude<br>quetiapine<br>fumarate)[2-[2-(4-dibenzo [b,f] [1,4]<br>thiazepin-11-yl-1-piperazinyl) ethoxy]<br>1 kg.<br>2<br>2-Amino thiophenol<br>0.50 kg.
Export Product Qty. Sl.<br>No. Import Items **Qty.

[2-[2-(4-dibenzo [b,f] [1,4]<br>thiazepin-11-yl-1-piperazinyl) ethoxy]<br>1 kg.<br>2<br>2-Amino thiophenol<br>0.50 kg.||||||| ||Export Product||Qty.|Sl.<br>No.|Import Items|Qty. allowed.| ||QUETI-VII-R<br>(Crude<br>quetiapine<br>fumarate)[2-[2-(4-dibenzo [b,f] [1,4]<br>thiazepin-11-yl-1-piperazinyl) ethoxy]||<br> <br> <br>1 kg.|1|2-Iodo benzoic acid|0.94 kg.| |||||2|2-Amino thiophenol|0.50 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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ethanolfumarate (2(QUETI-VII-R (Crude quetiapine fumarate) 2-[2-(4dibenzo [b,f] [1,4]thiazepin-11-yl-1piperazinyl) ethoxy]ethanolfumarate (2:1))

Case No. 39 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name FDC LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005320AM25
RA File Number 03AX04004931 AM25
Licence No and<br>Date 0311040073/01/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Gentamicin Eye/Ear Drops 5<br>Ml (Each Vial Contains<br>Gentamicin Sulphate 0.015 Gm<br>Net Wt of Bulk Drug Is 11.220<br>Kgs))<br>1 Number<br>Vial<br>1<br>Gentamicin Sulphate<br>(API)<br>18.377 mg/Vial<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 40 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Party Name PARADISE HEALTHCARE
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005333AM25
RA File Number 34AX04000854 AM25
Licence No and<br>Date 3411005897/01/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Percentage Yield on moler basis for each step of manufacturing process.<br>1.

ms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Percentage Yield on moler basis for each step of manufacturing process.<br>1.||

Case No. 41 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name SWATI CAMPHOR & SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005327AM25
RA File Number 05AX04003292 AM25
Licence No and<br>Date 0511030017/01/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete chemistry, chemical reaction and stichometric balance on molar basis with molecular weight and<br>percentage yield for each step of reaction.
Case No. 42 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005322AM25
RA File Number 07AX04001616 AM25
Licence No and<br>Date 0711013217/01/01/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Dec/202425/13 dated 07/01/2025 against advance authorization No. 0711002737 dated 28/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
Calcium<br>Dobesilate<br>Monohydrate<br>BP/<br>Calcium Dobesilate Monohydrate Eur.Ph /<br>Calcium Dobesilate <br> <br>1 kg. 1 Hydroquinone 0.631 kg.
Etamsylate / Etamsylate EP 1 kg. 2 Hydroquinone 0.527 kg.
Case No. Case No. 43 / NC/3/MEET/Jul/202526/6 43 / NC/3/MEET/Jul/202526/6 43 / NC/3/MEET/Jul/202526/6 43 / NC/3/MEET/Jul/202526/6 43 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005321AM25
RA File Number 07AX04001584 AM25
Licence No and<br>Date 0711013216/01/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Jun/202122/2 dated 02/07/2021 against advance<br>authorization No. 0711000987 dated 27/04/2021, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

/import item in meeting No. NC/3/MEET/Jun/202122/2 dated 02/07/2021 against advance<br>authorization No. 0711000987 dated 27/04/2021, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

1<br>Lactic Acid<br>0.560 kg.<br>7<br>Calcium Gluconate<br>0.686 kg.<br>Calcium Lactate Gluconate<br>1 kg<br>8<br>Calcium Carbonate<br>0.310 kg.<br>Ferrous Lactate<br>1 kg<br>2<br>Lactic Acid<br>1.028 kg.<br>Magnesium Lactate<br>1 kg<br>3<br>Lactic Acid<br>1.19 kg.<br>Zinc Lactate<br>1 kg<br>4<br>Lactic Acid<br>0.990 kg.<br>5<br>Lactic Acid<br>0.390 kg.<br>Magnesium Lactate Gluconate<br>1 kg.<br>10<br>Glucono Delta Lactone<br>0.617 kg.<br>6<br>Lactic Acid<br>0.922 kg.<br>Calcium Lactate<br>1 kg.<br>9<br>Calcium Carbonate<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC. Calcium Lactate Gluconate 1 kg 1 Lactic Acid 0.560 kg.
7 Calcium Gluconate 0.686 kg.
8 Calcium Carbonate 0.310 kg.
Ferrous Lactate 1 kg 2 Lactic Acid 1.028 kg.
Magnesium Lactate 1 kg 3 Lactic Acid 1.19 kg.
Zinc Lactate 1 kg 4 Lactic Acid 0.990 kg.
Magnesium Lactate Gluconate 1 kg. 5 Lactic Acid 0.390 kg.

errous Lactate|1 kg|2|Lactic Acid|1.028 kg.| ||Magnesium Lactate|1 kg|3|Lactic Acid|1.19 kg.| ||Zinc Lactate|1 kg|4|Lactic Acid|0.990 kg.| ||Magnesium Lactate Gluconate|1 kg.|5|Lactic Acid|0.390 kg.| ||||10|Glucono Delta Lactone|0.617 kg.| ||Calcium Lactate|1 kg.|6|Lactic Acid|0.922 kg.| ||||9|Calcium Carbonate|0.50 kg.|

Case No. 44 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name SWISS PARENTERALS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005357AM25
RA File Number 08AX04001575 AM25
Licence No and Date 0811013686/02/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

40

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Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Aztreonam for Injection<br>USP/BP/IP/CEP/EP/ChP 1 gm.<br>1 Number<br>1<br>Aztreonam for Injection<br>USP/BP/IP/CEP/EP/ChP<br>(Bulk Drug) (Dry Mixture for<br>Sterile Aztreonam & Arginine)<br>1.10 gm.<br>RA concerned may take further necessary action as per above decision of NC. Export Product Qty. Sl. No. Import Items Qty. allowed.
Aztreonam for Injection<br>USP/BP/IP/CEP/EP/ChP 1 gm. 1 Number 1 Aztreonam for Injection<br>USP/BP/IP/CEP/EP/ChP<br>(Bulk Drug) (Dry Mixture for<br>Sterile Aztreonam & Arginine) 1.10 gm.
Case No. 45 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005355AM25
RA File Number 03AX04005058 AM25
Licence No and<br>Date 0311040130/02/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>End use of export product.<br>1.<br>Justification of low yield of reaction (66%).<br>2.

per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>End use of export product.<br>1.<br>Justification of low yield of reaction (66%).<br>2.||

Case No. 46 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005418AM25
RA File Number 08AX04001666 AM25
Licence No and<br>Date 0811013691/03/01/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Mar/202324/26 dated 22/03/2024 against advance authorization No. 0811010634dated 01/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. Import Items Qty. allowed.
No.
Tranexamic Acid in 0.7% Sodium Chloride 1 Number 1 Tranexamic acid 1.05 gm/100 ml
Injection1000 mg per100 ml. (10 mg/ml.) (Injectable grade,US Vial
FDA approved)
Case No.<br>47 / NC/3/MEET/Jul/202526/6 Case No.<br>47 / NC/3/MEET/Jul/202526/6
Case Status<br>Case Approved
Party Name<br>STERIL-GENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number<br>HQRNORM APPLY 00005419AM25
RA File Number<br>04AX04000935 AM25
Licence No and<br>Date<br>0411008828/03/01/2025
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product Qty. Sl. No. Import Items Qty.

was decided to fix ad-hoc norms under Para 4.07||||||| |of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||||| |Export Product|Qty.||Sl. No.|Import Items|Qty. allowed.|| |Doxycycline for Injection USP|<br>1 Number||1|Doxycycline Hyclate (Drug)|118.80 mg/Vial|| |100 mg / Vial (Lyophilized)||||||| |20 Ml Vial (Injection)||||||| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

RA concerned may take further concerned may take further necessary act ion as p er above decision of NC.
Cas e No. 48 / NC/3/MEE T/Jul/202526/6
Cas e Status Case Withdraw n
Par ty Name NATURAL AN D ESSENTIAL OILS P RIVATE LIMITED
Me<br>and eting Number<br> NC/ 3/ MEET/ Jul/ 202526/ 6 a nd 31/07 /2025
Date
HQ File Number HQRNORM A PPLY 00005447 AM25
RA File Number 07AX04001593 AM25
Licence No and<br>Date ence No and<br>e 0711013254/03 /01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that export product applied by<br>the firm pertains to Norms Committee-6, therefore, it has been decided that the application of the firm may<br>be transferred to Norms Committee-6 for the fixation of ad-hoc norms.

the firm pertains to Norms Committee-6, therefore, it has been decided that the application of the firm may<br>be transferred to Norms Committee-6 for the fixation of ad-hoc norms.||||||| ||||||||
Case No. 49 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005456AM25
RA File Number 03AX04004828 AM25
Licence No and<br>Date 0311040186/06/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance<br>authorization No. 0311033331 dated 24/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.
Export Product Qty. Sl.<br>N Import Items Qty. allowed.
o.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

43

UDIN00261860AM26

ty. allowed.**| |||||||o.|||| |||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

43

UDIN00261860AM26

Doxyleb Capsule (Doxycycline 1 Number 1 Doxycycline Hyclate BP 115.40 mg.
Hyclate Capsule BP) 100 mg. (In
Packing of 10 X 10's , 10X100's,
1000's Qty Consumed of Exempt
Material Doxycyline Hyclate BP-
115.400 mg / CAPSULE)

Note: The Committee also recommended making a new SION for above export product. RA concerned may take further necessary action as per above decision of NC.

Case No. 50 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number NC/ 3/ MEET/ Jl/ 202526/ 6 d 31/07/2025
and Date u an
HQ File Number HQRNORM APPLY 00005473AM25
RA File Number 02AX04000630 AM25
Licence No and 0211007901/06/01/2025
Date
Norms Committee Decision:
The Committee considered the case as per the agenda and observed that the Authorisation has been issued<br>under Para 4.07 of the HBP. Para 4.07 (iii) of HBP prescribes that: No Authorisation under this paragraph<br>will be issued by the Regional Authority for items listed in paragraph 4.11 of FTP. Further, Para 4.11 of the<br>FTP states the following: Ineligible categories of import on Self Declaration basis (a) Import of the<br>following products shall not be permissible on a self-declaration basis: ix.

ra 4.11 of the<br>FTP states the following: Ineligible categories of import on Self Declaration basis (a) Import of the<br>following products shall not be permissible on a self-declaration basis: ix. Vitamins except for use in the<br>pharmaceutical industry; From the above combined reading of Para 4.07 of HBP and Para 4.11 of the FTP,<br>it is observed that the applicant intends to import Ascorbic Acid for the manufacture and export of Ferrous<br>Ascorbate, which is not for use in the pharmaceutical industry. Therefore, the Committee decided to seek|| |complete details from the applicant and the RA concerned as to how this Authorisation was issued when the<br>import of Vitamins is not permitted for any industry other than the pharmaceutical industry.||
Case No. 51 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name VIJAYASRI ORGANICS PRIVATE LIMITED
Meeting Number<br> NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
and Date

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

44

UDIN00261860AM26

ul/ 202526/ 6 and 31/07/2025| |and Date|| |||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

44

UDIN00261860AM26

HQ File Number HQRNORM APPLY 00005468AM25
RA File Number 09AX04000871 AM25
Licence No and<br>Date 0911008760/06/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Complete and balanced chemical reactions with moler weight and Percentage Yield on molar basis.<br>1.<br>Requirement and recovery of solvents at each step.<br>2.
Case No. Case No. 52 / NC/3/MEET/Jul/202526/6 52 / NC/3/MEET/Jul/202526/6 52 / NC/3/MEET/Jul/202526/6 52 / NC/3/MEET/Jul/202526/6 52 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005458AM25
RA File Number 03AX04005082 AM25
Licence No and<br>Date 0311040145/06/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Lampy-250 Capsule. Ampicillin Capsule<br>BP 250 Mg.

ls given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Lampy-250 Capsule. Ampicillin Capsule<br>BP 250 Mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 250<br>mg. Ampicillin Base. Net content of<br>Import/Exempt Material used in Export<br>Product 1) Ampicillin Trihydrate BP<br>(Compacted)-2018.539 Kg (Excl. 2 %<br>Wastage))<br>1 Number<br>1<br>Ampicillin Trihydrate<br>BP Compacted<br>294.5 mg.<br>Lampy-500 Capsule. Ampicillin Capsule<br>BP 500 mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 500<br>1 Number<br>2<br>Ampicillin Trihydrate<br>BP Compacted<br>589.0 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Lampy-250 Capsule. Ampicillin Capsule<br>BP 250 Mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 250<br>mg. Ampicillin Base. Net content of<br>Import/Exempt Material used in Export<br>Product 1) Ampicillin Trihydrate BP<br>(Compacted)-2018.539 Kg (Excl. 2 %<br>Wastage))||<br> <br>1 Number|1|Ampicillin Trihydrate<br>BP Compacted|294.5 mg.| ||Lampy-500 Capsule. Ampicillin Capsule<br>BP 500 mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 500||1 Number|2|Ampicillin Trihydrate<br>BP Compacted|589.0 mg.|

ed|294.5 mg.| ||Lampy-500 Capsule. Ampicillin Capsule<br>BP 500 mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 500||1 Number|2|Ampicillin Trihydrate<br>BP Compacted|589.0 mg.|

Case No. Case No. 52 / NC/3/MEET/Jul/202526/6 52 / NC/3/MEET/Jul/202526/6 52 / NC/3/MEET/Jul/202526/6 52 / NC/3/MEET/Jul/202526/6 52 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005458AM25
RA File Number 03AX04005082 AM25
Licence No and<br>Date 0311040145/06/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Lampy-250 Capsule. Ampicillin Capsule<br>BP 250 Mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 250<br>mg. Ampicillin Base. Net content of<br>Import/Exempt Material used in Export<br>Product 1) Ampicillin Trihydrate BP<br>(Compacted)-2018.539 Kg (Excl. 2 %<br>Wastage))<br>1 Number<br>1<br>Ampicillin Trihydrate<br>BP Compacted<br>294.5 mg.<br>Lampy-500 Capsule. Ampicillin Capsule<br>BP 500 mg.

picillin Trihydrate BP<br>(Compacted)-2018.539 Kg (Excl. 2 %<br>Wastage))<br>1 Number<br>1<br>Ampicillin Trihydrate<br>BP Compacted<br>294.5 mg.<br>Lampy-500 Capsule. Ampicillin Capsule<br>BP 500 mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 500<br>1 Number<br>2<br>Ampicillin Trihydrate<br>BP Compacted<br>589.0 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Lampy-250 Capsule. Ampicillin Capsule<br>BP 250 Mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 250<br>mg. Ampicillin Base. Net content of<br>Import/Exempt Material used in Export<br>Product 1) Ampicillin Trihydrate BP<br>(Compacted)-2018.539 Kg (Excl. 2 %<br>Wastage))||<br> <br>1 Number|1|Ampicillin Trihydrate<br>BP Compacted|294.5 mg.| ||Lampy-500 Capsule. Ampicillin Capsule<br>BP 500 mg. (Each Capsule Containing<br>Ampicillin Trihydrate Equivalent to 500||1 Number|2|Ampicillin Trihydrate<br>BP Compacted|589.0 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

45

UDIN00261860AM26

icillin Trihydrate<br>BP Compacted|589.0 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

45

UDIN00261860AM26

mg. Ampicillin Base. Net cont<br>Import/Exempt Material Used mg. Ampicillin Base. Net cont<br>Import/Exempt Material Used mg. Ampicillin Base. Net cont<br>Import/Exempt Material Used ent of<br>In Expor t
<br>Product 1) Ampicillin Trihydrate BP<br>(Compacted) -1155.411 Kg (Excl. 2%<br>
Wastage))
Lampyklox Capsule. Ampicillin<br>Trihydrate and Cloxacillin Sodium 1 Number 3 Ampicillin Trihydrate<br>BP Compacted 294.5 mg.
Capsules (25 0 mg + 250 mg) (Each
Capsule Cont<br> ains Ampicillin Trihydrate<br>
Equialent to<br> 250 mg of Ampicillin and<br>
Cloxacillin S<br>mg Cloxacill odium Equivalent To 250<br>in. Consumes Qty 1)
Ampicillin T<br> rihydrate BP (Compacted) -<br>
1606.736 kg (Excl. 2% Wastage))
Lampyklox D ry Syrup Ampicillin 1 Number 4 Ampicillin Trihydrate 29450 mg
RA .<br>Trihydrate and Cloxacillin Sodium<br>Suspension ((Each 5 ml Reconstituted<br>Suspension Contains Ampicillin<br>Trihydrate BP Equivalent to Ampicillin<br>BP 125 Mg ). Net Content of Import /<br>Exempt Material Used in Export Product<br>1) Ampicillin Trihydrate BP <br>Bottle <br>BP Compacted .

cillin<br>Trihydrate BP Equivalent to Ampicillin<br>BP 125 Mg ). Net Content of Import /<br>Exempt Material Used in Export Product<br>1) Ampicillin Trihydrate BP|||||<br>Bottle|||<br>BP Compacted|||. .| ||(Compacted)- 121.275kgs (E<br>Wastage)) 100 ml Bottle.||xcl 2%|||||||||| |||||||||||||| ||concerned may take further n||ecessary a|||||||||| ||||||ction as p||er above decision of NC.|||||| |||||||||||||| |||||||||||||| |Case No.||53 / NC/3/MEET/Jul/202526/6||||||||||| |Case Status||Case Approved||||||||||| |Party Name||HARMONY ORGANICS PVT LTD||||||||||| |Meeting Number<br>and Date||NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025||||||||||| |HQ File Number||HQRNORM APPLY 00005457AM25||||||||||| |RA File Number||31AX04000364 AM25||||||||||| |Licence No and||3111004275/06/01/2025|||||||||||

Case No. 53 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name HARMONY ORGANICS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005457AM25
RA File Number 31AX04000364 AM25
Licence No and 3111004275/06/01/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

46

UDIN00261860AM26

Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

ion:

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
Cinnamic Alcohol 1 kg. 1 Sodium Borohydride 0.10 kg.
Case No.<br>54 / NC/3/MEET/Jul/202526/6
Case Status<br>Case Approved
Party Name<br>LIVEALTH BIOPHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number<br>HQRNORM APPLY 00005476AM25
RA File Number<br>03AX04005038 AM25
Licence No and<br>Date<br>0311040211/06/01/2025
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty. Sl. No. Import Items Qty. allowed.
Hesperin Diosmin Micronized 50<br>607860 1 Diosmin Plus Hespiridin 310 kg.
MG /450 MG TABLETS 3X10<br>Numbers (90:10))
TABS ALU ALU (20262 PACKS
OF 3X10 TABS))
RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

47

UDIN00261860AM26

sary action as per above decision of NC.|||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

47

UDIN00261860AM26
Cas e No. 55 / NC/3/MEET/Jul/202526/6
Cas e Status Case Approved
Par ty Name ENCUBE ETHICALS PRIVATE L IMITED
Me<br>and eting Number
Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 3 /07/2025
HQ File Number HQRNORM APPLY 00005453AM 25
RA File Number 03AX04004912 AM25
Lic<br>Dat ence No and<br>e 0311040176/06/01/2025
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to fix ad-hoc norms as under:-<br>Sl. No<br>Export Product<br>Quantity ms Committee Decision:<br>e Committee considered the reuest of fir m for fixatio n of ad -hoc norms and o the basis of
**Sl.

as under:-<br>Sl. No<br>Export Product<br>Quantity||ms Committee Decision:<br>e Committee considered the reuest of fir||||m for fixatio|||n of ad||-hoc norms and o||the basis of|| ||Sl. No||Export Product<br>|||||||||||Quantity| |||||||||||||||| ||1||MEDICAL CREAM AND OINTMENT (Betamethasone Dipropionate Cream<br>USP 0.05% 15 gm tube (Tot Wt: 946.04 Kgs (Net Cont: Sod 2.84 Kgs, Poly 17.03<br>Kgs Ceto 68.11 Kgs Wh Petro 141.91 Kgs Min 56.76 Kgs Pre 0.95 Kgs Prop<br>|||||||||||<br> <br> <br>1 Number| ||||,<br>47.30|, , , ,<br>Kgs, Beta 0.66 Kgs, Tube 63069 Nos)))||||||||||| |||||||||||||||| |||||<br>||||||||||<br>| ||2||MED<br>USP 0<br>|CAL CREAM AND OINTMENT(Betamethasone Dipropionate Cream<br>.05% 45 gm tube (Tot Wt: 4455 Kgs (Net Cont: Sod 13.77 Kgs, Poly 80.19<br> <br>||||||||||<br> <br> <br>1 Number| ||||Kgs,<br>|eto 320.76 Kgs, Wh Petro 668.25 Kgs, Min 267.30 Kgs, Pre 4.46 Kgs, Prop<br>||||||||||| ||||222.7|Kgs, Beta 3.12 Kgs, Tube 99000 Nos)))||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| ||S. No||Import Product||||Quantity allowed.|||||||| ||1||Relevant Bulk Drugs||||Net content in the export product plus 2% wastage.|||||||| ||2||Relevant Excipients||||Net|content i||n the export produc||t plus 2% wastage.||| ||3|||||||||||||| ||||Relevant Packaging Material||||Rel|evant as||per Packing Policy||General Notes.||| ||N|ote:<br>The firm will declare net weight of imp<br>i.|||ort items (Rel|||evant Bul||k Drugs and Excipien||ts) in export to the RA||| ||||||||||||||||

Packing Policy||General Notes.||| ||N|ote:<br>The firm will declare net weight of imp<br>i.|||ort items (Rel|||evant Bul||k Drugs and Excipien||ts) in export to the RA||| ||||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

48

UDIN00261860AM26

concerned for redemption.

Case No. 56 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005495AM25
RA File Number 08AX04001675 AM25
Licence No and<br>Date 0811013728/07/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against advance<br>authorization No. 0811011115 dated 27/03/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Magnesium Sulfate In Water for<br>Injection (0.325 mEq mg ++ / ml) 40 mg<br>/mL 2 g Total<br>1 Number<br>1<br>Magnesium Sulfate<br>Heptahydrate PhEur<br>2.00 gm.<br>Magnesium Sulfate In Water for<br>Injection (0.325 mEq mg ++ / ml) 40 mg<br>/mL 4 g Total<br>1 Number<br>2<br>Magnesium Sulfate<br>Heptahydrate PhEur<br>4.00 gm.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 57 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

LIMITED| |Meeting Number|NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

49

UDIN00261860AM26

and Date
HQ File Number<br>HQRNORM APPLY 00005518AM25
RA File Number<br>03AX04004853 AM25
Licence No and<br>Date<br>0311040267/08/01/2025
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty. Sl. No. Import Items Qty. allowed.
Nitrofurantoin Anhydrous<br>1 kg. 1 5-Nitrofurfural Diacetate 1.13 kg.
2 1-Aminohydantion HCl 0.59 kg.
RA concerned may take further necessary action as per above decision of NC.
Case No.<br>58 / NC/3/MEET/Jul/202526/6
Case Status<br>Case Approved
Party Name<br>AEGIS LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number<br>HQRNORM APPLY 00005511AM25
RA File Number<br>08AX04001694 AM25
Licence No and<br>Date<br>0811013741/08/01/2025
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty. **Sl.

agenda and it was decided to fix ad-hoc norms under Para 4.07||||| |of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||| |Export Product<br>Qty.|Sl. No.|Import Items|Qty. allowed.|| |SURGI-ORC ORIGINAL 2X3 10000|1|Oxidized Cellulose Sheet,|10000 Pieces||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

50

UDIN00261860AM26

INCH<br>(Oxidized Regenerated Regenerated <br>Pieces 5.1 x 7.6 cm
Cellulose)
INCH<br>(Oxidized<br>Regenerated<br>Cellulose)<br>Pieces<br>5.1 x 7.6 cm INCH<br>(Oxidized<br>Regenerated<br>Cellulose) INCH<br>(Oxidized<br>Regenerated<br>Cellulose) <br>Pieces <br>Pieces <br>Pieces 5.1 x 7.6 cm 5.1 x 7.6 cm 5.1 x 7.6 cm 5.1 x 7.6 cm
RA concerned m ay take further necessary action as per above decision of NC.
Case No. 59 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005552AM25
RA File Number 08AX04001721 AM25
Lic<br>Dat ence No and<br>e 0811013766/09/01/2025

6 and 31/07/2025||||||||||||| |HQ File Number||HQRNORM APPLY 00005552AM25||||||||||||| |RA File Number||08AX04001721 AM25||||||||||||| |Lic<br>Dat|ence No and<br>e|0811013766/09/01/2025||||||||||||| |Nor<br>Th<br>pr<br>au<br>H|ms Committee Decision:<br>e Committee considered the case as per|||agenda and ta|||king cue f|||rom the earlier decisio|||n for same export|| ||oduct/import item in meeting No. N<br>thorization No. 0811007029 dated 16/0<br>BP Vol. I as per details given below or as|||C/3/MEET/Se<br>1/2023, it was<br>applied by th|||p/202425/<br>decided t<br>e firm, wh|||9 dated 10/10/2024<br>o fix ad-hoc norms un<br>ichever is less:-|||against advance<br>der Para 4.07 of|| |||||||||||||||| ||Export Product||||Qty.||||Sl. No.||Import Items|||Qty. allowed.| ||Esmolol Hydrochloride in Sodium<br>Chloride Injection 2,500 mg /250 ml (10<br>mg/ml)||||1 Number||||1||ESMOLOL|||2625 mg.| |||||||||||||||| ||Esmolol Hydrochloride in Sodium<br>Chloride Injection [Double Strength]<br>2,000 mg/100 ml (20 mg/ml)||||1 Number||||2||ESMOLOL|||2100 mg.| |||||||||||||||| |RA concerned m||ay take further necessary action as per above decision of NC.||||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |Case No.||60 / NC/3/MEET/Jul/202526/6||||||||||||| |Case Status||Case Approved|||||||||||||

Case No. 60 / NC/3/MEET/Jul/202526/6
Case Status Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

51

UDIN00261860AM26

2526/6| |---|---| |Case Status|Case Approved|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

51

UDIN00261860AM26

Party Name<br>VINEET LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number<br>HQRNORM APPLY 00005559AM25
RA File Number<br>09AX04000933 AM25
Licence No and<br>Date<br>0911008809/09/01/2025
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No. NC/3/MEET/May/202526/3 dated 04/06/2025 against advance
authorization No. 0311038141 dated 22/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty. Sl. No. Import Items Qty. allowed.
N Butyl Lithium 30% w/w in Hexane<br>1 kg. 1 N Butyl Chloride 0.540 kg.
Solution
2 Lithium Metal 0.0812 kg.
3 n-Hexane 1.450 kg.
RA concerned may take further necessary action as per above decision of NC.

r>1 kg.|1||N Butyl Chloride|0.540 kg.|| |Solution|||||| ||2||Lithium Metal|0.0812 kg.|| ||3||n-Hexane|1.450 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No. 61 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005564AM25
RA File Number 03AX04004855 AM25
Licence No and<br>Date 0311040319/09/01/2025
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

52

UDIN00261860AM26

Case No. 62 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name USV PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005565AM25
RA File Number 03AX04005196 AM25
Licence No and<br>Date 0311040320/09/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Oct/202122/10 dated 12/11/2021 against advance<br>authorization No. 0311000899 dated 12//01/2021, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

mport item in meeting No. NC/3/MEET/Oct/202122/10 dated 12/11/2021 against advance<br>authorization No. 0311000899 dated 12//01/2021, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>Perphenazine Tablets USP 8 MG 100 S<br>1 Tablet<br>1<br>Perphenazine USP<br>8.16 mg/8 mg<br>Tablet<br>Perphenazine Tablets USP 16 MG 100 S<br>1 Tablet<br>2<br>Perphenazine USP<br>16.32 mg/16 mg<br>Tablet<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 63 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005567AM25
RA File Number 05AX04003524 AM25
Licence No and<br>Date 0511030211/09/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

53

UDIN00261860AM26

product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance authorization No. 0510413195 dated 03/01/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

nst advance authorization No. 0510413195 dated 03/01/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
Sclareolide 1 kg. 1 Sclareol 1.29 kg.
Case No. 64 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name AARTI PHARMALABS LIMITED
Meeting Number
<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005550AM25
RA File Number 03AX04004964 AM25
Licence No and<br>Date 0311040297/09/01/2025
Norms Committee Decision:<br>NC decided to defer the case for next meeting.
Case No. 65 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number
and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005547AM25
RA File Number 08AX04001719 AM25
Licence No and
Date 0811013761/09/01/2025
Norms Committee<br> Decision:<br>
The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Nov/202425/10 dated 22/11/2024 against advance<br>authorization No. 0811011484 dated 09/05/2024, it was decided to fix ad-hoc norms under Para 4.07 of

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

54

UDIN00261860AM26

ided to fix ad-hoc norms under Para 4.07 of||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

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UDIN00261860AM26

HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
Ropivacaine Hydrochloride Inj 200 mg/100 Ml 1 Vial 1 Ropivacaine 210 mg/Vial
Ropivacaine Hydrochloride Inj 400 mg/200 mL 1 Vial 2 Ropivacaine 420 mg/Vial
Ropivacaine Hydrochloride Inj 500 mg/100 mL 1 Vial 3 Ropivacaine 525 mg/Vial
Case No. 66 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name STYRAX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005543AM25
RA File Number 09AX04000950 AM25
Licence No and<br>Date 0911008795/09/01/2025
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,
it was decided to call for following information/documents from the firm:-
Complete<br>1. and balanced chemical reactions with molecular weight and Percentage Yield on molar
basis.
Technical justification for requirement of import item no. 2 and its recovery.<br>2.
  1. Complete and balanced chemical reactions with molecular weight and Percentage Yield on molar basis.

.|| |Technical justification for requirement of import item no. 2 and its recovery.<br>2.||

  1. Complete and balanced chemical reactions with molecular weight and Percentage Yield on molar basis.
Case No. 67 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name SANOFI CONSUMER HEALTHCARE INDIA LIMITED
Meeting Number<br> NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
and Date
HQ File Number HQRNORM APPLY 00005571AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

55

UDIN00261860AM26

RA File Number 03AX04005178 AM25
Licence No and<br>Date 0311040324/10/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Jun/202324/6 dated 14/06/2023 against advance<br>authorization No. 0311021689 dated 24/02/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Festal Dragees (Tablets) Enterosoluble<br>10x10s ((Total Net Content of Pancreatin<br>in Export Quantity 18691.60 KGS<br>Strength of Pancreatin 192 MG /Tablet))<br>1 Number<br>Tablet<br>1<br>Pancreatin<br>195.84 mg.<br>RA concerned may take further necessary action as per above decision of NC.

tity 18691.60 KGS<br>Strength of Pancreatin 192 MG /Tablet))<br>1 Number<br>Tablet<br>1<br>Pancreatin<br>195.84 mg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. Case No. 68 / NC/3/MEET/Jul/202526/6 68 / NC/3/MEET/Jul/202526/6 68 / NC/3/MEET/Jul/202526/6 68 / NC/3/MEET/Jul/202526/6 68 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name DEEPAK NOVOCHEM SPECIALITIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005592AM25
RA File Number 31AX04000333 AM25
Licence No and<br>Date 3111004304/10/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Phenol<br>0.96 kg.<br>2<br>Methanol<br>0.10 kg.<br>DNOVO BP818 DGE<br>(Tetra<br>Methyl<br>Bisphenol<br>F<br>1 kg.
Export Product Qty. Sl. No. Import Items Qty. allowed.
DNOVO BP818 DGE<br>(Tetra<br>Methyl<br>Bisphenol<br>F <br>1 kg. 1 Phenol 0.96 kg.
2 Methanol 0.10 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

56

UDIN00261860AM26

|1|Phenol|0.96 kg.| |||||2|Methanol|0.10 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

56

UDIN00261860AM26

3<br>Paraformaldehyde<br>0.13 kg.<br>4<br>Epichlorohydrine<br>0.60 kg.<br>5<br>Caustic Soda Lye<br>0.228 kg.<br>6<br>Toluene<br>0.20 kg.<br>Diglycidyl Ether)<br>7<br>Catalyst<br>0.004 kg.<br>RA concerned may take further necessary action as per above decision of NC. Diglycidyl Ether) 3 Paraformaldehyde 0.13 kg.
4 Epichlorohydrine 0.60 kg.
5 Caustic Soda Lye 0.228 kg.
6 Toluene 0.20 kg.
7 Catalyst 0.004 kg.
Case No. 69 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005596AM25
RA File Number 05AX04003551 AM25
Licence No and<br>Date 0511030251/10/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Step wise complete and balanced chemical reactions with molecular weight and Percentage Yield on<br>moler basis.<br>1.<br>Detailed working for import item no 3, 6 and 7.<br>2.<br>Consumption Coefficient (CC) for API used.<br>3.
  1. Step wise complete and balanced chemical reactions with molecular weight and Percentage Yield on moler basis.

t item no 3, 6 and 7.<br>2.<br>Consumption Coefficient (CC) for API used.<br>3.||

  1. Step wise complete and balanced chemical reactions with molecular weight and Percentage Yield on moler basis.
Case No. 70 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name CIRON DRUGS AND PHARMACEUTICALS PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

57

UDIN00261860AM26

and Date
HQ File Number HQRNORM APPLY 00005622AM25
RA File Number 03AX04005211 AM25
Licence No and<br>Date 0311040388/13/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. 8/82-ALC4/2018 dated 31/08/2018 against advance authorization No.<br>0510405339 dated 12/01/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Bimatoprost Opthalmic Solution 0.3<br>mg /ml - 3 ml (Each ml contains<br>Bimatoprost 0.3 mg) (2,50,000 Nos)<br>(Net Content : Bimatoprost -0.225<br>KGS)<br>1 Number<br>1<br>Bimatoprost<br>0.90 mg/3 ml Vial<br>RA concerned may take further necessary action as per above decision of NC.

g) (2,50,000 Nos)<br>(Net Content : Bimatoprost -0.225<br>KGS)<br>1 Number<br>1<br>Bimatoprost<br>0.90 mg/3 ml Vial<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. Case No. 71 / NC/3/MEET/Jul/202526/6 71 / NC/3/MEET/Jul/202526/6 71 / NC/3/MEET/Jul/202526/6 71 / NC/3/MEET/Jul/202526/6 71 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name ADCOCK INGRAM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005635AM25
RA File Number 07AX04001696 AM25
Licence No and<br>Date 0711013341/13/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>IBUPROFEN BP/USP/EP<br>204.00 mg.<br>IBUPROFEN 200 mg +<br>CODEINE PHOSPHATE<br>1 Number
Export Product Qty. Sl. No. Import Items Qty. allowed.
IBUPROFEN 200 mg +<br>CODEINE PHOSPHATE 1 Number 1 IBUPROFEN BP/USP/EP 204.00 mg.

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

58

UDIN00261860AM26

or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

58

UDIN00261860AM26

12.8mg Tablets (IBUPROFEN<br>200 mg + CODEINE<br>PHOSPHATE 13.169mg<br>Tablets (IBU-600.00+COD-<br>39.507 KGS, No of Tabs<br>3000000) BP/USP/EP)<br>1 Number<br>2<br>CODEINE PHOSPHATE<br>BP/EP/USP/ PH.EUR<br>13.056 mg.<br>CO-CODAMOL 15 mg / 500<br>mg TABLETS (CO-<br>CODAMOL 15.432 mg / 500<br>mg TABLETS (PARA 500 mg<br>+ CODEINE PHOSPHATE<br>15.432 mg) (PARA-<br>15000+COD-462.960 KGS<br>(No of Tabs 30000000)<br>BP/EP/USP/ PH.EUR)<br>3<br>CODEINE PHOSPHATE<br>BP/USP/EP/ PH.EUR<br>15.30 mg.<br>RA concerned may take further necessary action as per above decision of NC. 12.8mg Tablets (IBUPROFEN<br>200 mg + CODEINE<br>PHOSPHATE 13.169mg<br>Tablets (IBU-600.00+COD-<br>39.507 KGS, No of Tabs<br>3000000) BP/USP/EP) <br>1 Number 2 CODEINE PHOSPHATE<br>BP/EP/USP/ PH.EUR 13.056 mg.
CO-CODAMOL 15 mg / 500<br>mg TABLETS (CO-<br>CODAMOL 15.432 mg / 500<br>mg TABLETS (PARA 500 mg<br>+ CODEINE PHOSPHATE<br>15.432 mg) (PARA-<br>15000+COD-462.960 KGS<br>(No of Tabs 30000000)<br>BP/EP/USP/ PH.EUR) 3 CODEINE PHOSPHATE<br>BP/USP/EP/ PH.EUR 15.30 mg.

br>mg TABLETS (PARA 500 mg<br>+ CODEINE PHOSPHATE<br>15.432 mg) (PARA-<br>15000+COD-462.960 KGS<br>(No of Tabs 30000000)<br>BP/EP/USP/ PH.EUR)||3|CODEINE PHOSPHATE<br>BP/USP/EP/ PH.EUR|15.30 mg.|

Case No. Case No. 72 / NC/3/MEET/Jul/202526/6 72 / NC/3/MEET/Jul/202526/6 72 / NC/3/MEET/Jul/202526/6 72 / NC/3/MEET/Jul/202526/6 72 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005634AM25
RA File Number 05AX04003571 AM25
Licence No and<br>Date 0511030286/13/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>Visallergol<br>Eye<br>Drops<br>0.2%,<br>2.5<br>ml<br>(Visallergol Eye Drops 0.2%, 2.5 ml)<br>1 Number<br>1<br>Olopatadine HCL<br>5.61 mg.
Export Product Qty. Sl. No. Import Items Qty.<br>allowed.
Visallergol<br>Eye<br>Drops<br>0.2%,<br>2.5<br>ml<br>(Visallergol Eye Drops 0.2%, 2.5 ml) <br>1 Number 1 Olopatadine HCL 5.61 mg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

59

UDIN00261860AM26

ml)||<br>1 Number|1|Olopatadine HCL|5.61 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

59

UDIN00261860AM26

Oftahist (Olopatadine Eye Solution 0.1<br>Percent in 5ml Vial)(Oftahist (Olopatadine<br>Eye Solution 0.1 Percent in 5ml Vial))<br>1 Number<br>2<br>Olopatadine HCL<br>5.61 mg.<br>RA concerned may take further necessary action as per above decision of NC. Oftahist (Olopatadine Eye Solution 0.1<br>Percent in 5ml Vial)(Oftahist (Olopatadine<br>Eye Solution 0.1 Percent in 5ml Vial)) 1 Number 2 Olopatadine HCL 5.61 mg.
Case No. 73 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name VINDHYA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005621AM25
RA File Number 09AX04000885 AM25
Licence No and<br>Date 0911008835/13/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Percentage Yield on moler basis at each step of manufacturing process with technical literature in<br>support of it.<br>1.<br>Justification for requirement of import items no 3 & 4.<br>2.<br>Regeneration and recovery of import item no. 4.<br>3.
  1. Percentage Yield on moler basis at each step of manufacturing process with technical literature in support of it.

ms no 3 & 4.<br>2.<br>Regeneration and recovery of import item no. 4.<br>3.||

  1. Percentage Yield on moler basis at each step of manufacturing process with technical literature in support of it.
Case No. 74 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name USV PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005644AM25
RA File Number 03AX04005232 AM25
Licence No and<br>Date 0311040406/14/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

60

UDIN00261860AM26

authorization No. 0311029676 dated 27/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

61860AM26

authorization No. 0311029676 dated 27/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
Propafenone HCL ER Capsules USP<br>225 MG 60 s us (Ris ((6,999 Bottles<br>X 60 Capsules Per Bottles = 4,19940<br>Capsules ) (Total Weight of Export<br>Product = 94.487 Kgs) 1 Number<br>Capsule 1 Propafenone<br>Hydrochloride 229.5 mg/Capsule
Propafenone HCL ER Capsules USP<br>325 MG 60s us (Ris ((14,585 Bottles<br>X 60 Capsules Per Bottles =<br>8,75,100 Capsules ) (Total Weight of<br>Export Product = 284.408 Kgs) <br>1 Number<br>Capsule 2 Propafenone<br>Hydrochloride 331.5 mg/Capsule
Propafenone HCL ER Capsules USP<br>425 MG 60 s us (Ris((2,333 Bottles<br>X 60 Capsules Per Bottles =<br>1,39,980 Capsules ) (Total Weight of<br>Export Product = 59.492 Kgs) <br>1 Number<br>Capsule 3 Propafenone<br>Hydrochloride 433.5 mg/Capsule
Case No. 75 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name MEDREICH LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005657AM25
RA File Number 07AX04001691 AM25
Licence No and<br>Date 0711013347/15/01/2025
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

61

UDIN00261860AM26

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
Clindamycin Hydrochloride 300 mg<br>Capsules ([Each Capsule contains<br>Clindamycin Hydrochloride 325.78 mg<br>equivalent to Clindamycin 300 mg]<br>990.432 KG) 1 Number 1 Clindamycin<br>Hydrochloride 332.29 mg.
Case No. Case No. 76 / NC/3/MEET/Jul/202526/6 76 / NC/3/MEET/Jul/202526/6 76 / NC/3/MEET/Jul/202526/6 76 / NC/3/MEET/Jul/202526/6 76 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name MANKIND PHARMA LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00005654AM25
RA File Number 05AX04003570 AM25
Licence No and Date 0511030315/15/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ROCURONIUM BROMIDE<br>INJECTION 50 MG /5 ML, (5<br>mL)<br>1 Number<br>1<br>ROCURONIUM<br>BROMIDE USP<br>55.735 mg/5 ml Vial<br>Rocuronium Bromide Injection<br>100 MG / 10 ML, (10 mL)<br>1 Number<br>2<br>ROCURONIUM<br>BROMIDE USP<br>110.326 mg/10 ml<br>Vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ROCURONIUM BROMIDE<br>INJECTION 50 MG /5 ML, (5<br>mL)||1 Number|1|ROCURONIUM<br>BROMIDE USP|55.735 mg/5 ml Vial| ||Rocuronium Bromide Injection<br>100 MG / 10 ML, (10 mL)||1 Number|2|ROCURONIUM<br>BROMIDE USP|110.326 mg/10 ml<br>Vial|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

62

UDIN00261860AM26

Case No. 77 / NC/3/MEET/Jul/202526/6
Case Status Case Deferred
Party Name ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00006239AM25
RA File Number 32AX04000749 AM25
Licence No and<br>Date 3211008445/14/02/2025

| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025| |HQ File Number|HQRNORM APPLY 00006239AM25| |RA File Number|32AX04000749 AM25| |Licence No and<br>Date|3211008445/14/02/2025| |Norms Committee Decision:<br>The Committee considered the request of the firm for fixation of ad-hoc norms and on the basis<br>ofinformation provided by the firm and it has been observed by the committee that export product “<br>Secondary Butyl Quinoline” (Perfumery Compound) as applied by the firm appears to fall under para<br>4.11(b) of FTP, 2023, and the said para states that “For export of perfumes, perfumery compounds and<br>various feeding redients containing vitamins, no authorisation shall be issued by Regional Authority under<br>para 4.07 of HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of<br>HBP, and the RA concerned is also directed to provide their comments on the same.||

Case No. Case No. 78 / NC/3/MEET/Jul/202526/6 78 / NC/3/MEET/Jul/202526/6 78 / NC/3/MEET/Jul/202526/6 78 / NC/3/MEET/Jul/202526/6 78 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00006288AM25
RA File Number 03AX04005901 AM25
Licence No and<br>Date 0311041469/18/02/2025

and Date||NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025||||| |HQ File Number||HQRNORM APPLY 00006288AM25||||| |RA File Number||03AX04005901 AM25||||| |Licence No and<br>Date||0311041469/18/02/2025||||| |Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Mar/202324/26 dated 22/03/2024 against advance authorization<br>No.0311030597 dated 01/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items<br>|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

63

UDIN00261860AM26

|1<br>Tylosin Tartrate BP/USP /EP<br>0.101 kg.<br>TYLODOX GOLD WSP (Pack size 1 Kgs<br>Jar)(Each gram contains: Tylosin Tartrate BP<br>(Vet) 100 mg, Doxycycline Hyclate BP 200 mg)<br>1 Number<br>3<br>Doxycycline Hyclate BP/EP/USP<br>0.202 kg.<br>2<br>Tylosin Tartrate BP/USP /EP<br>10.1 gm.<br>TYLODOX GOLD WSP (Pack size 100 Gms<br>sachet)(Each gram contains: Tylosin Tartrate<br>BP (Vet) 100 mg, Doxycycline Hyclate BP 200<br>mg)<br>1 Number<br>4<br>Doxycycline Hyclate BP/EP/USP<br>20.2 gm.<br>GENTADOX GOLD 100 / 200 ( pack Size 1<br>Kgs Jar) (Each gram powder contains:<br>Doxycycline Hyclate BP 200 mg,<br>Gentamycin Sulphate USP 100mg)

r<br>4<br>Doxycycline Hyclate BP/EP/USP<br>20.2 gm.<br>GENTADOX GOLD 100 / 200 ( pack Size 1<br>Kgs Jar) (Each gram powder contains:<br>Doxycycline Hyclate BP 200 mg,<br>Gentamycin Sulphate USP 100mg)<br>1 Number<br>5<br>Doxycycline Hyclate BP/EP/USP<br>0.202 kg.<br>GENTADOX GOLD 100 /200 ( pack Size 100<br>Gms Sachet) (Each gram powder contains:<br>Doxycycline Hyclate BP 200mg, Gentamycin<br>Sulphate USP 100mg)<br>1 Number<br>6<br>Doxycycline Hyclate BP/EP/USP<br>20.2 gm.<br>NEODOX GOLD WSP (pack Size 1 Kgs<br>Jar)(Each gram contains: Doxycycline Hyclate<br>BP 100 mg Neomycin Sulfate BP 100 mg)<br>1 Number<br>7<br>Doxycycline Hyclate BP/EP/USP<br>0.101 kg.<br>NEODOX -GOLD WSP (pack Size 100 Gms<br>Sachet) (Each gram contains: Doxycycline<br>Hyclate BP 100 mg Neomycin Sulfate BP 100<br>mg)<br>1 Number<br>8<br>Doxycycline Hyclate BP/EP/USP<br>10.1 gm.<br>RA concerned may take further necessary action as per above decision of NC. TYLODOX GOLD WSP (Pack size 1 Kgs<br>Jar)(Each gram contains: Tylosin Tartrate BP<br>(Vet) 100 mg, Doxycycline Hyclate BP 200 mg) 1 Number 1 Tylosin Tartrate BP/USP /EP 0.101 kg.
3 Doxycycline Hyclate BP/EP/USP 0.202 kg.
TYLODOX GOLD WSP (Pack size 100 Gms<br>sachet)(Each gram contains: Tylosin Tartrate<br>BP (Vet) 100 mg, Doxycycline Hyclate BP 200<br>mg) 1 Number 2 Tylosin Tartrate BP/USP /EP 10.1 gm.
4 Doxycycline Hyclate BP/EP/USP 20.2 gm.

ms<br>sachet)(Each gram contains: Tylosin Tartrate<br>BP (Vet) 100 mg, Doxycycline Hyclate BP 200<br>mg)|1 Number|2|Tylosin Tartrate BP/USP /EP|10.1 gm.| ||||4|Doxycycline Hyclate BP/EP/USP|20.2 gm.| ||GENTADOX GOLD 100 / 200 ( pack Size 1<br>Kgs Jar) (Each gram powder contains:<br>Doxycycline Hyclate BP 200 mg,<br>Gentamycin Sulphate USP 100mg)|1 Number|5|Doxycycline Hyclate BP/EP/USP|0.202 kg.| ||GENTADOX GOLD 100 /200 ( pack Size 100<br>Gms Sachet) (Each gram powder contains:<br>Doxycycline Hyclate BP 200mg, Gentamycin<br>Sulphate USP 100mg)|1 Number|6|Doxycycline Hyclate BP/EP/USP|20.2 gm.| ||NEODOX GOLD WSP (pack Size 1 Kgs<br>Jar)(Each gram contains: Doxycycline Hyclate<br>BP 100 mg Neomycin Sulfate BP 100 mg)|1 Number|7|Doxycycline Hyclate BP/EP/USP|0.101 kg.| ||NEODOX -GOLD WSP (pack Size 100 Gms<br>Sachet) (Each gram contains: Doxycycline<br>Hyclate BP 100 mg Neomycin Sulfate BP 100<br>mg)|1 Number|8|Doxycycline Hyclate BP/EP/USP|10.1 gm.|

Case No. 79 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00006528AM25
RA File Number 03AX04006116 AM25
Licence No and<br>Date 0311041802/04/03/2025
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

64

UDIN00261860AM26

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ACEPRO-MAL Oral Paste /<br>Acepromazine Oral paste,<br>Each ml contains:<br>Acepromazine maleate USP<br>12 mg (Pack Size 30ml) (Net<br>wt. of Acepromazine maleate<br>USP 1872.00 Grams)<br>5200 Numbers<br>1<br>Acepromazine maleate<br>USP<br>1909.44 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 6 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 1890.00<br>Grams)<br>7000 Numbers<br>2<br>Selamectin BP / EP / USP<br>1927.8 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75ml<br>x 1 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 67.50<br>Grams)<br>1500 Numbers<br>3<br>Selamectin BP / EP / USP<br>68.85 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 3 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small D

x 3 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 90.00 Grams)<br>1500 Numbers<br>5<br>Selamectin BP / EP / USP<br>91.8 gm.|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ACEPRO-MAL Oral Paste /<br>Acepromazine Oral paste,<br>Each ml contains:<br>Acepromazine maleate USP<br>12 mg (Pack Size 30ml) (Net<br>wt. of Acepromazine maleate<br>USP 1872.00 Grams)<br>5200 Numbers<br>1<br>Acepromazine maleate<br>USP<br>1909.44 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 6 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 1890.00<br>Grams)<br>7000 Numbers<br>2<br>Selamectin BP / EP / USP<br>1927.8 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75ml<br>x 1 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 67.50<br>Grams)<br>1500 Numbers<br>3<br>Selamectin BP / EP / USP<br>68.85 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 3 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (

Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 90.00 Grams)<br>1500 Numbers<br>5<br>Selamectin BP / EP / USP<br>91.8 gm.|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ACEPRO-MAL Oral Paste /<br>Acepromazine Oral paste,<br>Each ml contains:<br>Acepromazine maleate USP<br>12 mg (Pack Size 30ml) (Net<br>wt. of Acepromazine maleate<br>USP 1872.00 Grams)<br>5200 Numbers<br>1<br>Acepromazine maleate<br>USP<br>1909.44 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 6 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 1890.00<br>Grams)<br>7000 Numbers<br>2<br>Selamectin BP / EP / USP<br>1927.8 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75ml<br>x 1 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 67.50<br>Grams)<br>1500 Numbers<br>3<br>Selamectin BP / EP / USP<br>68.85 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 3 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack

tes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 90.00 Grams)<br>1500 Numbers<br>5<br>Selamectin BP / EP / USP<br>91.8 gm.|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ACEPRO-MAL Oral Paste /<br>Acepromazine Oral paste,<br>Each ml contains:<br>Acepromazine maleate USP<br>12 mg (Pack Size 30ml) (Net<br>wt. of Acepromazine maleate<br>USP 1872.00 Grams)<br>5200 Numbers<br>1<br>Acepromazine maleate<br>USP<br>1909.44 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 6 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 1890.00<br>Grams)<br>7000 Numbers<br>2<br>Selamectin BP / EP / USP<br>1927.8 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75ml<br>x 1 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 67.50<br>Grams)<br>1500 Numbers<br>3<br>Selamectin BP / EP / USP<br>68.85 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 3 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<

(Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 90.00 Grams)<br>1500 Numbers<br>5<br>Selamectin BP / EP / USP<br>91.8 gm.|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ACEPRO-MAL Oral Paste /<br>Acepromazine Oral paste,<br>Each ml contains:<br>Acepromazine maleate USP<br>12 mg (Pack Size 30ml) (Net<br>wt. of Acepromazine maleate<br>USP 1872.00 Grams)<br>5200 Numbers<br>1<br>Acepromazine maleate<br>USP<br>1909.44 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 6 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 1890.00<br>Grams)<br>7000 Numbers<br>2<br>Selamectin BP / EP / USP<br>1927.8 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75ml<br>x 1 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 67.50<br>Grams)<br>1500 Numbers<br>3<br>Selamectin BP / EP / USP<br>68.85 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 3 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.

ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 90.00 Grams)<br>1500 Numbers<br>5<br>Selamectin BP / EP / USP<br>91.8 gm.|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ACEPRO-MAL Oral Paste /<br>Acepromazine Oral paste,<br>Each ml contains:<br>Acepromazine maleate USP<br>12 mg (Pack Size 30ml) (Net<br>wt. of Acepromazine maleate<br>USP 1872.00 Grams)<br>5200 Numbers<br>1<br>Acepromazine maleate<br>USP<br>1909.44 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 6 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 1890.00<br>Grams)<br>7000 Numbers<br>2<br>Selamectin BP / EP / USP<br>1927.8 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75ml<br>x 1 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 67.50<br>Grams)<br>1500 Numbers<br>3<br>Selamectin BP / EP / USP<br>68.85 gm.<br>Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 3 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1

r>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)<br>5000 Numbers<br>4<br>Selamectin BP / EP / USP<br>688.5 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 90.00 Grams)<br>1500 Numbers<br>5<br>Selamectin BP / EP / USP<br>91.8 gm.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||ACEPRO-MAL Oral Paste /<br>Acepromazine Oral paste,<br>Each ml contains:<br>Acepromazine maleate USP<br>12 mg (Pack Size 30ml) (Net<br>wt. of Acepromazine maleate<br>USP 1872.00 Grams)|5200 Numbers|1|Acepromazine maleate<br>USP|1909.44 gm.| ||Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 6 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 1890.00<br>Grams)|<br>7000 Numbers|2|Selamectin BP / EP / USP|1927.8 gm.| ||Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75ml<br>x 1 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 67.50<br>Grams)|<br>1500 Numbers|3|Selamectin BP / EP / USP|68.85 gm.| ||Radicate / SELGARD Spot On<br>6% For Cat (Pack size 0.75 ml<br>x 3 Pipettes) (Each ml<br>contains Selamectin BP / EP<br>60 mg, Net Weight = 675.00<br>Grams)|<br>5000 Numbers|4|Selamectin BP / EP / USP|688.5 gm.| ||Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 90.00 Grams)|1500 Numbers|5|Selamectin BP / EP / USP|91.8 gm.|

Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5 x 1 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 90.00 Grams)|1500 Numbers|5|Selamectin BP / EP / USP|91.8 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

65

UDIN00261860AM26

|Radicate Spot on 12% for Dog<br>(Medium Dog) (Pack size 1 ml<br>x 1 pipettes), (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 180.00 Grams)<br>1500 Numbers<br>6<br>Selamectin BP / EP / USP<br>183.6 gm.<br>Radicate Spot on 12% for Dog<br>(Large Dog) (Pack size 2 ml x<br>1 pipettes), (Each ml contains:<br>Selamectin BP 12%, Net<br>Weight = 192.00 Grams)<br>800 Numbers<br>7<br>Selamectin BP / EP / USP<br>195.84 gm.<br>Radicate Spot on 12% for Dog<br>(Extra Large Dog) (Pack size<br>3 ml x 1 pipettes), (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 288.00 Grams)<br>800 Numbers<br>8<br>Selamectin BP / EP / USP<br>293.76 gm.<br>Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5ml x 6 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 270.00 Grams)<br>750 Numbers<br>9<br>Selamectin BP / EP / USP<br>275.4 gm.<br>Radicate Spot On 12% For<br>Dog (Medium Dog) (Pack size<br>1ml x 6 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 540.00 Grams)<br>750 Numbers<br>10<br>Selamectin BP / EP / USP<br>550.8 gm.<br>Radicate Spot On 12% For<br>Dog (Large Dog) (Pack size<br>2ml x 6 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 1080.00 Grams)<br>750 Numbers<br>11<br>Se

EP / USP<br>550.8 gm.<br>Radicate Spot On 12% For<br>Dog (Large Dog) (Pack size<br>2ml x 6 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 1080.00 Grams)<br>750 Numbers<br>11<br>Selamectin BP / EP / USP<br>1101.6 gm.<br>RA concerned may take further necessary action as per above decision of NC. Radicate Spot on 12% for Dog<br>(Medium Dog) (Pack size 1 ml<br>x 1 pipettes), (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 180.00 Grams) <br>1500 Numbers 6 Selamectin BP / EP / USP 183.6 gm.
Radicate Spot on 12% for Dog<br>(Large Dog) (Pack size 2 ml x<br>1 pipettes), (Each ml contains:<br>Selamectin BP 12%, Net<br>Weight = 192.00 Grams) 800 Numbers 7 Selamectin BP / EP / USP 195.84 gm.
Radicate Spot on 12% for Dog<br>(Extra Large Dog) (Pack size<br>3 ml x 1 pipettes), (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 288.00 Grams) 800 Numbers 8 Selamectin BP / EP / USP 293.76 gm.
Radicate Spot On 12% For<br>Dog (Small Dog) (Pack size<br>0.5ml x 6 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 270.00 Grams) 750 Numbers 9 Selamectin BP / EP / USP 275.4 gm.
Radicate Spot On 12% For<br>Dog (Medium Dog) (Pack size<br>1ml x 6 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 540.00 Grams) <br>750 Numbers 10 Selamectin BP / EP / USP 550.8 gm.
Radicate Spot On 12% For<br>Dog (Large Dog) (Pack size<br>2ml x 6 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 1080.00 Grams) 750 Numbers 11 Selamectin BP / EP / USP 1101.6 gm.

cate Spot On 12% For<br>Dog (Large Dog) (Pack size<br>2ml x 6 Pipettes) (Each ml<br>contains: Selamectin BP 12%,<br>Net Weight = 1080.00 Grams)|750 Numbers|11|Selamectin BP / EP / USP|1101.6 gm.|

Case No. 80 / NC/3/MEET/Jul/202526/6

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

66

UDIN00261860AM26

Case Status Case Approved
Party Name B M CHEMIE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00006830AM25
RA File Number 03AX04006075 AM25
Licence No and<br>Date 0311042394/24/03/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>Progesterone BP<br>Micronised<br>1 kg.<br>1<br>(20S)- 21-Hydroxy-20-Methylpregn-4EN-3-One<br>1.167 kg.<br>RA concerned may take further necessary action as per above decision of NC.

allowed.<br>Progesterone BP<br>Micronised<br>1 kg.<br>1<br>(20S)- 21-Hydroxy-20-Methylpregn-4EN-3-One<br>1.167 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. Case No. 81 / NC/3/MEET/Jul/202526/6 81 / NC/3/MEET/Jul/202526/6 81 / NC/3/MEET/Jul/202526/6 81 / NC/3/MEET/Jul/202526/6 81 / NC/3/MEET/Jul/202526/6
Case Status Case Approved
Party Name B M CHEMIE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202526/ 6 and 31/07/2025
HQ File Number HQRNORM APPLY 00001231AM26
RA File Number 03AX04001069 AM26
Licence No and<br>Date 0311044422/02/06/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>Progesterone BP<br>Micronised<br>1 kg.<br>1<br>(20S)- 21-Hydroxy-20-Methylpregn-4EN-3-One<br>1.167 kg.
Export Product Qty. Sl.<br>No. Import Items Qty.<br>allowed.
Progesterone BP<br>Micronised 1 kg. 1 (20S)- 21-Hydroxy-20-Methylpregn-4EN-3-One 1.167 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

67

UDIN00261860AM26

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 19-Aug-2025 18:28:31 Reason: ramankumar@nic.in Location: DGFT(HQ)

68

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